Product Code: HPX FDA unclassified

Lens, Contact (Polymethylmethacrylate)

Unknown

A Contact Lens (Polymethylmethacrylate) is a rigid gas-impermeable contact lens made from polymethylmethacrylate (PMMA) plastic, worn directly on the corneal surface to correct refractive errors such as myopia, hyperopia, and astigmatism. This device is currently unclassified by the FDA and does not have an assigned regulation number or medical specialty designation. It carries product code HPX and is reviewed by the Ophthalmic panel.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HPX
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955777	PMMA CLASIC	May 16, 1996	Substantially Equivalent	Rand Scientific Corp.
K940106	KERATOPLASTY SUTURING LENS	May 25, 1994	Substantially Equivalent	Visionary Technologies of Miami, Inc.
K913081	MULTI-VIEW BIFOCALS	Oct 23, 1991	Substantially Equivalent	Camp Contact Lenses
K897021	MARTIN-HENSLEY SEGMENT LENS	Jun 22, 1990	Substantially Equivalent	Bruce W. Martin O.D. and Edward Hensley
K895411	OPTIKEM PMMA CONTACT LENS	Feb 27, 1990	Substantially Equivalent	Optikem Polymers, Inc.
K874591	ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY	May 03, 1988	Substantially Equivalent	Vitreo Dynamics, Co.
K865111	CHARTER HARD CONTACT LENS CLEANING SOLUTION	Jan 20, 1987	Substantially Equivalent	Paco Pharmaceutical Services, Inc.
K864343	BL1 (HARD CONTACT LENS)	Nov 28, 1986	Substantially Equivalent	Beta Labs, Inc.
K863974	CHARTER LABORATORIES INC. LENS LUBRICANT	Nov 10, 1986	Substantially Equivalent	Paco Pharmaceutical Services, Inc.
K862952	CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES	Sep 25, 1986	Substantially Equivalent	Paco Pharmaceutical Services, Inc.
K862811	AQUALUX LENS CASE	Sep 03, 1986	Substantially Equivalent	Safeway Products, Inc.
K861643	STYLEKEEPER CONTACT LENS CARRYING CASE	Jun 02, 1986	Substantially Equivalent	Allergan, Inc.
K861712	WETTING & SOAKING HARD CONTACT LENS SOLUTION	May 29, 1986	Substantially Equivalent	Maurry Biological Co.
K861642	LENSKEEPER CONTACT LENS CARRYING CASE	May 29, 1986	Substantially Equivalent	Allergan, Inc.
K860677	EASY EYES TM LENS CARRYING CASE	May 29, 1986	Substantially Equivalent	Applied Laboratories, Inc.
K854968	BAUSCH & LOMB LENS CARRYING CASE	Apr 04, 1986	Substantially Equivalent	Bausch & Lomb, Inc.
K853809	DAILY HARD CONTACT LENS CLEANER	Mar 11, 1986	Substantially Equivalent	Maurry Biological Co.
K853808	HARD CONTACT LENS CLEANING & SOAKING SOLUTION	Mar 11, 1986	Substantially Equivalent	Maurry Biological Co.
K854442	UVASORB-400	Feb 19, 1986	Substantially Equivalent	Optatint, Inc.
K853811	HARD CONTACT LENS SOAKING SOLUTION	Dec 16, 1985	Substantially Equivalent	Maurry Biological Co.
K853810	WETTING SOLUTION FOR HARD CONTACT LENSES	Dec 16, 1985	Substantially Equivalent	Maurry Biological Co.
K853807	ALL-IN-ONE HARD CONTACT LENS SOLUTION	Dec 16, 1985	Substantially Equivalent	Maurry Biological Co.
K853729	KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)	Dec 13, 1985	Substantially Equivalent	Ryder Intl. Corp.
K853728	KESTREL CONTACT LENS STORAGE CASE(NORYL)	Dec 13, 1985	Substantially Equivalent	Ryder Intl. Corp.
K853870	EASY EYES TM LENS CARRYING CASE	Dec 10, 1985	Substantially Equivalent	Applied Laboratories, Inc.
K853445	IN A WINK LUBRICATING & REWETTING DROPS	Nov 29, 1985	Substantially Equivalent	Ciba Vision Care
K850909	RHODA-LUX LENS BLANKS	Oct 04, 1985	Substantially Equivalent	Optatint, Inc.
K852384	SIGHT SAVER ALL PURPOSE LENS CARRYING CASE	Jul 31, 1985	Substantially Equivalent	Bausch & Lomb, Inc.
K851887	ON TARGET	May 30, 1985	Substantially Equivalent	Newman Assoc.
K851497	MARLIN CONTACT LENS CASE	May 16, 1985	Substantially Equivalent	Marlin Industries
K850046	PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE	Apr 15, 1985	Substantially Equivalent	Professional Supplies, Inc.
K841881	EASY EYES TM LENS CARRYING CASE	Dec 03, 1984	Substantially Equivalent	Eaton Medical Corp.
K843342	LENSKEEPER LENS CARRYING CASE	Nov 19, 1984	Substantially Equivalent	Allergan Pharmaceuticals, Inc.
K833903	BENZETHONIUM CHLORIDE	May 30, 1984	Substantially Equivalent	Blairex Laboratories, Inc.
K831973	HARD CONTACT LENS CASE	Oct 19, 1983	Substantially Equivalent	Moonbeam International, Inc.
K832706	SENSITIVE EYES	Oct 04, 1983	Substantially Equivalent	Bausch & Lomb, Inc.
K832810	HARD CONTACT LENS CLEANER	Sep 29, 1983	Substantially Equivalent	Blairex Laboratories, Inc.
K830740	CLERZ LUBRICATING & REWETTING EYE DROPS	Jun 02, 1983	Substantially Equivalent	CooperVision, Inc.
K823528	GLISLENS	Dec 22, 1982	Substantially Equivalent	Bio-Products, Inc.
K822315	GFB-B CONTACT LENS BLANKS	Nov 16, 1982	Substantially Equivalent	Hamel, Park, Mccabe & Saunders
K822706	PRE-SERT	Oct 22, 1982	Substantially Equivalent	Allergan, Inc.
K822707	CLEAN-N-SOAK	Oct 18, 1982	Substantially Equivalent	Allergan, Inc.
K822495	LE CASE HARD CONTACT LENS STORAGE CASE	Sep 30, 1982	Substantially Equivalent	Optikem International, Inc.
K821866	OXY-PMMA	Sep 14, 1982	Substantially Equivalent	Petrarch Systems & Professional Pharm
K822105	LENS EASY ON	Aug 20, 1982	Substantially Equivalent	L.E.O. Corp.
K821054	TOTAL	May 13, 1982	Substantially Equivalent	Allergan, Inc.
K821052	SOAKARE	May 13, 1982	Substantially Equivalent	Allergan, Inc.
K821051	LIQUIFILM WETTING SOLUTION	May 13, 1982	Substantially Equivalent	Allergan, Inc.
K821055	BLINK-N-CLEAN	May 10, 1982	Substantially Equivalent	Allergan, Inc.
K820817	OPTACRY/95 GRAY CONTACT LENS BLANKS	May 05, 1982	Substantially Equivalent	Optacryl, Inc.
K820816	OPTACRY/ 95 GREEN CONTACT LENS BLANKS	May 05, 1982	Substantially Equivalent	Optacryl, Inc.
K820815	OPTACRY/95 BLUE CONTACT LENS BLANKS	May 05, 1982	Substantially Equivalent	Optacryl, Inc.
K820325	STERICIDAL	Apr 21, 1982	Substantially Equivalent	Breger Mueller West
K820818	CONCENTRATED CLEANER FOR HARD CONTACTS	Apr 09, 1982	Substantially Equivalent	Bausch & Lomb, Inc.
K820511	BAUSCH & LOMB STERILE ALL PURPOSE SOLU	Apr 09, 1982	Substantially Equivalent	Bausch & Lomb, Inc.
K813528	LENS-PAC	Jan 12, 1982	Substantially Equivalent	The Plactory
K811010	CONTACT LENS MATERL	Dec 09, 1981	Substantially Equivalent	Paragon Optical Co.
K812433	LENSINE EXTRA STRENGTH CLEANER	Sep 21, 1981	Substantially Equivalent	CooperVision, Inc.
K812172	CONTACT LENS CLEANER	Aug 31, 1981	Substantially Equivalent	Alcon Laboratories
K812135	BARNES-HIND WEEKLY CLEANER	Aug 31, 1981	Substantially Equivalent	Barnes-Hind, Inc.
K810130	OPTOCRYL CONTACT LENS BLANKS	Jun 11, 1981	Substantially Equivalent	Optacryl, Inc.
K802593	KERATOPLASTY SUTURING LENS	Dec 22, 1980	Substantially Equivalent	Paris Contact Lens Laboratory
K800582	BARNES-HOND HARD CONTACT LENS STOR. CASE	Mar 25, 1980	Substantially Equivalent	Barnes-Hind, Inc.
K800192	DURALITE LENS	Mar 12, 1980	Substantially Equivalent	American Optical Corp.
K791523	VISALENS ALL PURPOSE SOLUTION FOR LENS	Feb 19, 1980	Substantially Equivalent	Pfizer, Inc.
K792224	CONTACT LENSES MADE OF POLYMETHYLMETHACR	Dec 11, 1979	Substantially Equivalent	Contact Lenses of the Pacific, Inc.
K791524	VISALENS CONCENTRATED CLEANER CONT LENS	Nov 20, 1979	Substantially Equivalent	Pfizer, Inc.
K781007	AUTO-CON	Jun 30, 1978	Substantially Equivalent	Barnes-Hind, Inc.
K780823	CONTACT LENS CLEANSER	Jun 30, 1978	Substantially Equivalent	Ketchum Laboratories, Inc.
K770582	LENS, CONTACT, HARD	May 06, 1977	Substantially Equivalent	Berea Contact Lens, Inc.
K760046	CASE, CONTACT LENS, PLASTIC	Oct 21, 1976	Substantially Equivalent	Tomlin B. Horsley, Jr.
K760213	LENSES, CONTACT, POLYMETHYL METHACRYLATE	Aug 09, 1976	Substantially Equivalent	Progressive Affiliated Labs, Inc.
K760204	BUTTONS, PMMA (FOR CONTACT LENSES)	Aug 04, 1976	Substantially Equivalent	Burton Parsons & Co., Inc.
K760126	LENS, HARD CONTACT	Jul 20, 1976	Substantially Equivalent	Tru-Form Optics, Inc.