Product Code: HQD FDA class 2 21 CFR 886.5916

Lens, Contact (Other Material) - Daily

Ophthalmic

A Daily Wear Contact Lens (Other Material) is a soft or rigid contact lens made from materials other than PMMA or traditional hydrogel, intended to be worn on the cornea during waking hours only and removed nightly, to correct refractive vision errors. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQD and is regulated under 21 CFR 886.5916, within the Ophthalmic medical specialty. It is eligible for third-party review.

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510(k)s

118

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HQD
Device Class: FDA class 2
Regulation Number: 886.5916
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 118 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253822	GPA (hexafocon A) Rigid Gas Permeable Contact Lenses	Mar 27, 2026	Substantially Equivalent	Zhuhai Fitlens Medical Technology Co., Ltd.
K242393	Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses	Nov 01, 2024	Substantially Equivalent	Acuity Polymers, Inc.
K241398	SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses	Oct 22, 2024	Substantially Equivalent	Tianjin Mastervision Technology Co., Ltd.
K241571	BostonSight® Specialty Lenses	Aug 14, 2024	Substantially Equivalent	Boston Foundation For Sight, Inc. D/B/A Bostonsight
K240618	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens	Apr 03, 2024	Substantially Equivalent	Acuity Polymers, Inc.
K233325	Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)	Feb 21, 2024	Substantially Equivalent	Visionary Optics, LLC
K230965	Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens	Jun 16, 2023	Substantially Equivalent	Acuity Polymers, Inc.
K230910	NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens	Jun 16, 2023	Substantially Equivalent	Acculens, Inc.
K221768	Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses	May 05, 2023	Substantially Equivalent	Paragon Vision Sciences, Inc.
K223394	Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)	Dec 07, 2022	Substantially Equivalent	Visionary Optics, LLC
K212631	Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses	Mar 17, 2022	Substantially Equivalent	Contamac, Ltd.
K213880	Custom Stable Rigid Gas Permeable Scleral Contact Lens	Jan 07, 2022	Substantially Equivalent	Valley Contax, Inc.
K213538	Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Dec 30, 2021	Substantially Equivalent	Acuity Polymers, Inc.
K202860	Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)	May 11, 2021	Substantially Equivalent	Valley Contax, Inc.
K203571	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Apr 09, 2021	Substantially Equivalent	Acuity Polymers, Inc.
K201194	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Sep 08, 2020	Substantially Equivalent	Acuity Polymers, Inc.
K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens	Feb 12, 2019	Substantially Equivalent	Bausch & Lomb, Incorporated
K183175	BostonSight Scleral	Jan 04, 2019	Substantially Equivalent	Bostonsight
K182304	Hyper GP (tisilfocon A) Daily Wear Contact Lens	Nov 23, 2018	Substantially Equivalent	Contamac, Ltd.
K181579	eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K	Jul 26, 2018	Substantially Equivalent	E&E Optics, Inc.
K180988	Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens	Jun 08, 2018	Substantially Equivalent	Acuity Polymers, Inc.
K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens	Apr 25, 2018	Substantially Equivalent	Contamac, Ltd.
K180172	FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG	Mar 16, 2018	Substantially Equivalent	Paragon Vision Sciences
K171575	ENFLU 18 (enflufocon A) Daily Wear Contact Lens	Oct 24, 2017	Substantially Equivalent	Contamac, Ltd.
K172314	Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)	Sep 20, 2017	Substantially Equivalent	Art Optical Contact Lens, Inc.
K171950	Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)	Aug 16, 2017	Substantially Equivalent	Visionary Optics, LLC
K171077	HEXA100 (hexafocon A) Daily Wear Contact Lenses	Aug 01, 2017	Substantially Equivalent	Contamac, Ltd.
K171404	BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)	Jul 17, 2017	Substantially Equivalent	Bausch + Lomb, Incorporated
K170001	Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens	Jun 02, 2017	Substantially Equivalent	Acuity Polymers, Inc.
K170007	Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens	May 31, 2017	Substantially Equivalent	Acuity Polymers, Inc.
K170335	Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens	Mar 24, 2017	Substantially Equivalent	Valley Contax, Inc.
K163254	Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens	Jan 18, 2017	Substantially Equivalent	Acuity Polymers, Inc.
K162005	Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens	Dec 08, 2016	Substantially Equivalent	Acuity Polymers, Inc.
K153714	SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co	Nov 15, 2016	Substantially Equivalent	Synergeyes, Inc.
K161100	Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses	Aug 10, 2016	Substantially Equivalent	Contamac, Ltd.
K160938	SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens	Aug 01, 2016	Substantially Equivalent	Synergeyes, Inc.
K161461	BostonSight PD Prosthetic Device	Jul 25, 2016	Substantially Equivalent	Bostonsight
K152724	EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES	Apr 27, 2016	Substantially Equivalent	Advanced Vision Technologies
K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Feb 09, 2016	Substantially Equivalent	Boston Foundation For Sight
K142510	UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens	Nov 19, 2014	Substantially Equivalent	Synergeyes, Inc.
K120996	FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN	Jun 28, 2012	Substantially Equivalent	Paragon Vision Sciences
K113586	SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS	Apr 18, 2012	Substantially Equivalent	Synergeyes, Inc.
K103561	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	Feb 03, 2011	Substantially Equivalent	Menicon Co, Ltd.
K102154	TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS	Jan 21, 2011	Substantially Equivalent	The Lagado Corp.
K083921	SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS	May 20, 2009	Substantially Equivalent	Synergeyes, Inc.
K082799	HDS HI 1.54	Jan 27, 2009	Substantially Equivalent	Paragon Vision Sciences
K081178	OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES	Oct 09, 2008	Substantially Equivalent	Contamac, Ltd.
K081443	MENICON Z RIGID GAS PERMEABLE CONTACT LENS	Sep 23, 2008	Substantially Equivalent	Menicon Co, Ltd.
K081034	SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS	May 30, 2008	Substantially Equivalent	Synergeyes, Inc.
K080193	SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR	Mar 05, 2008	Substantially Equivalent	Synergeyes, Inc.
K073184	BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS	Feb 21, 2008	Substantially Equivalent	Bausch & Lomb, Inc.
K071266	BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS	Aug 15, 2007	Substantially Equivalent	Bausch & Lomb, Inc.
K071043	BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES	Aug 02, 2007	Substantially Equivalent	Bausch & Lomb, Inc.
K070637	FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES	May 01, 2007	Substantially Equivalent	Paragon Vision Sciences
K070628	OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.	May 01, 2007	Substantially Equivalent	Contamac, Ltd.
K062548	MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	Nov 01, 2006	Substantially Equivalent	Contamac, Ltd.
K061120	SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES	Jun 22, 2006	Substantially Equivalent	Synergeyes, Inc.
K060102	SYNERGEYES PS HYBRID CONTACT LENS	Mar 15, 2006	Substantially Equivalent	Synergeyes, Inc.
K052983	FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES	Feb 10, 2006	Substantially Equivalent	Paragon Vision Sciences
K053124	BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES	Jan 30, 2006	Substantially Equivalent	Bausch & Lomb, Incorporated
K052675	SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS	Nov 30, 2005	Substantially Equivalent	Synergeyes
K052507	TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR	Nov 02, 2005	Substantially Equivalent	The Lagado Corp.
K051035	SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS	Sep 02, 2005	Substantially Equivalent	Synergeyes
K033599	ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS	Sep 16, 2004	Substantially Equivalent	The Lagado Corp.
K033594	OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	Mar 19, 2004	Substantially Equivalent	Contamac, Ltd.
K024164	COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT	Feb 12, 2003	Substantially Equivalent	Metro Optics, Inc.
K021752	FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL	Oct 11, 2002	Substantially Equivalent	Lucid Korea Co., Ltd.
K021977	HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR	Sep 12, 2002	Substantially Equivalent	Contamac, Ltd.
K022128	BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	Aug 22, 2002	Substantially Equivalent	Bausch & Lomb, Incorporated
K013646	ROSE K POST GRAFT LENS	May 30, 2002	Substantially Equivalent	Rose K International , Ltd.
K013310	PVS BASIC 2; EPIC 2	Apr 25, 2002	Substantially Equivalent	Paragon Vision Sciences
K013762	RIGID GAS PERMEABLE CONTACT LENS	Apr 03, 2002	Substantially Equivalent	Bausch & Lomb, Incorporated
K020006	DYNA INTRA-LIMBAL LENS	Mar 29, 2002	Substantially Equivalent	Lens Dynamics, Inc.
K011945	RIGID GAS PERMEABLE CONTACT LENS SOLUTION	Sep 12, 2001	Substantially Equivalent	Polymer Technology Corp.
K010454	THE ALBERTA LENS SM2, SULFOCON B	Aug 01, 2001	Substantially Equivalent	Progressive Optical Research , Ltd.
K011914	HYDRO2, HS-75	Jul 27, 2001	Substantially Equivalent	Innovision, Inc.
K003932	BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY	Feb 16, 2001	Substantially Equivalent	Polymer Technology
K002845	PAFLUFOCON C AND E DAILY CONTACT LENS	Dec 08, 2000	Substantially Equivalent	Paragon Vision Sciences
K002703	O-PERM 30	Nov 21, 2000	Substantially Equivalent	Optical Polymer Research, Inc.
K002025	RIGID GAS PERMEABLE CONTACT LENS	Oct 31, 2000	Substantially Equivalent	Polymer Technology
K001960	RIGID GAS PERMEABLE CONTACT LENS	Aug 28, 2000	Substantially Equivalent	Polymer Technology
K000795	RIGID GAS PERMEABLE CONTACT LENS	May 26, 2000	Substantially Equivalent	Polymer Technology
K993586	SPORTSIGHT GP	May 22, 2000	Substantially Equivalent	Paragon Vision Sciences
K000233	MENICON SF-P	May 19, 2000	Substantially Equivalent	Menicon Co, Ltd.
K000133	MENICON Z	May 19, 2000	Substantially Equivalent	Menicon U.S.A., Inc.
K000485	HYDRO2, HS-75	May 12, 2000	Substantially Equivalent	Innovision, Inc.
K992787	EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR	Feb 02, 2000	Substantially Equivalent	Specialty Ultravision, Inc.
K991781	FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS	Jun 29, 1999	Substantially Equivalent	G.T. Laboratories, Inc.
K991780	FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C	Jun 29, 1999	Substantially Equivalent	G.T. Laboratories, Inc.
K984436	PVS BASICS	Apr 21, 1999	Substantially Equivalent	Paragon Vision Sciences
K990895	OXYCON LENS	Apr 14, 1999	Substantially Equivalent	Concise Contact Lens Co.
K990264	COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS	Mar 31, 1999	Substantially Equivalent	Metro Optics of Austin, Inc.
K980197	ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR	Aug 04, 1998	Substantially Equivalent	Specialty Ultravision, Inc.
K980741	BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)	May 11, 1998	Substantially Equivalent	Polymer Technology Div. Wilmington Partners, L.P.
K974636	FLOSI RIGID GAS PERMEABLE CONTACT LENS	Mar 30, 1998	Substantially Equivalent	Futuristic Design Assoc.
K972443	MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS	Aug 22, 1997	Substantially Equivalent	Menicon U.S.A., Inc.
K963744	BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)	Jul 31, 1997	Substantially Equivalent	Benz Research and Development Corp.
K963512	BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL	Jul 31, 1997	Substantially Equivalent	Benz Research and Development Corp.
K970698	BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS	May 06, 1997	Substantially Equivalent	Polymer Technology Corp.
K963010	LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR	Nov 20, 1996	Substantially Equivalent	Permeable Technologies, Inc.
K962006	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	Oct 09, 1996	Substantially Equivalent	Menicon Co, Ltd.
K962934	AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR	Aug 27, 1996	Substantially Equivalent	Airperm, Inc.
K960584	NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY	Aug 15, 1996	Substantially Equivalent	Novavision, Inc.
K955366	TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS	Mar 28, 1996	Substantially Equivalent	Rand Scientific Corp.
K955900	NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR	Mar 25, 1996	Substantially Equivalent	Novavision, Inc.
K954124	O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS	Mar 19, 1996	Substantially Equivalent	Optical Polymer Research, Inc.
K952260	OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)	Jan 03, 1996	Substantially Equivalent	Stellar Contact Lens, Inc.
K952165	TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS	Jun 30, 1995	Substantially Equivalent	Rand Scientific Corp.
K945955	ROSE K LENS	Feb 07, 1995	Substantially Equivalent	Rose K International , Ltd.
K944223	ACCUCON	Dec 07, 1994	Substantially Equivalent	Innovision, Inc.
K941883	CONTACT LENS	Oct 28, 1994	Substantially Equivalent	Airperm, Inc.
K943784	MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR	Oct 20, 1994	Substantially Equivalent	Menicon Co, Ltd.
K943177	BOSTON(R) 7 - 30(ENFLUFOCON A)	Aug 25, 1994	Substantially Equivalent	Polymer Technology Corp.
K942533	NOVALENS/NOVAWET PERCEPTION AND VANGUARD	Aug 05, 1994	Substantially Equivalent	Ocutec Corporation, Inc.
K942365	BOSTON VII	Jun 23, 1994	Substantially Equivalent	Polymer Technology Corp.
K940277	PAFLUFOCON A, B, C & D	May 09, 1994	Substantially Equivalent	Paragon Vision Sciences
K841163	CONTACT LENS INSERTER/REMOVER	Jun 01, 1984	Substantially Equivalent	Optimum Manufacturers, Inc.
K840115	SWISS OPTICAL PRODUCTS-CONTACT CASE	Jun 01, 1984	Substantially Equivalent	Moonbeam International, Inc.