Product Code: LRX
FDA class 2
21 CFR 886.5928
Case, Contact Lens
Ophthalmic
The Contact Lens Case is a small container used to store soft or rigid contact lenses when not in use, designed to hold lenses in an appropriate lens care solution to maintain hydration, cleanliness, and sterility. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRX, regulated under 21 CFR 886.5928, within the Ophthalmic medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
80
FEI Numbers
43
Registration Numbers
43
Unique Applicants
56
Years Active
40
Basic Information
- Product Code
- LRX
- Device Class
- FDA class 2
- Regulation Number
- 886.5928
- 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
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Related 510(k) Clearances
This FDA classification is associated with 80 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240095 | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | Oct 09, 2024 | Substantially Equivalent | Shanghai Care Us Medical Product Co., Ltd. |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | Aug 30, 2023 | Substantially Equivalent | Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Dec 04, 2017 | Substantially Equivalent | Alcon Laboratories, Inc. |
| K172925 | Contact Lens Case, Model: A-1, B-1 | Nov 30, 2017 | Substantially Equivalent | P L Overseas Limited |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Nov 17, 2017 | Substantially Equivalent | Bausch & Lomb Incorporated |
| K171539 | Contact Lens Case | Jul 14, 2017 | Substantially Equivalent | E-Link Plastic & Metal Industrial Co.,Ltd |
| K171163 | Contact Lens Case Round Glasses | Jun 27, 2017 | Substantially Equivalent | FiftyTwoWays Ltd |
| K162869 | Contact Lens Case | Dec 09, 2016 | Substantially Equivalent | Ningbo Yinzhou Zonghai Artware Co., Ltd. |
| K160005 | Contact Lens Case (multiple brand name) | Jun 07, 2016 | Substantially Equivalent | DANYANG CHANXIN GLASSES CASES FACTORY |
| K142717 | Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case | May 07, 2015 | Substantially Equivalent | Ni Hau Industrial Co., Ltd. |
| K143351 | iCase Contact Lens Case | Apr 29, 2015 | Substantially Equivalent | Novabay Pharmaceuticals, Inc |
| K140488 | CONTACT LENS CASE | Sep 10, 2014 | Substantially Equivalent | MACA PLASTICS, INC. |
| K131783 | POLAROID CONTACTSPOD | Feb 21, 2014 | Substantially Equivalent | VIOPTI LTD |
| K130930 | OWL CONTACT LENS CASES, DOG CONTACT LENS CASES | Feb 12, 2014 | Substantially Equivalent | NINGBO LISHUNDA ELECTRONICS CO., LTD. |
| K131875 | MENICON NECT CONTACT LENS CASE | Aug 06, 2013 | Substantially Equivalent | FORESIGHT REGULATORY STRATEGIES |
| K130753 | STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE | Jun 13, 2013 | Substantially Equivalent | WATCHDOG GROUP, LC |
| K122700 | PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES | May 31, 2013 | Substantially Equivalent | PROSBEN, INC. |
| K130285 | PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS | Apr 03, 2013 | Substantially Equivalent | THE LAGADO CORP. |
| K120904 | POLARIS DIAL-A-DATE CONTACT LENS CASE | Nov 26, 2012 | Substantially Equivalent | RELIANCE DESIGN & MANUFACTURE CORP. |
| K120969 | AC LENS BRANDED CONTACT LENS CASE | Jul 11, 2012 | Substantially Equivalent | ARLINGTON CONTACT LENS SERVICES,INC. |
| K121030 | SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE | Jul 06, 2012 | Substantially Equivalent | SACKS HOLDINGS, INC. |
| K112832 | EYE CARE CURE CONTACT LENS CASE | Dec 05, 2011 | Substantially Equivalent | EYE CARE AND CURE |
| K111856 | SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE | Jul 14, 2011 | Substantially Equivalent | APOTHECARY PRODUCTS, INC. |
| K093377 | POLARIS CONTACT LENS CASE | Apr 27, 2010 | Substantially Equivalent | RELIANCE DESIGN & MANUFACTURING CORP. |
| K090362 | IMAG, IPOD, EZ-FIND AND ISLIDE | Feb 27, 2009 | Substantially Equivalent | VOGUESTRAP |
| K071081 | CONTACT LENS CASE | May 01, 2007 | Substantially Equivalent | NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT |
| K052809 | SAUFLON FLAT COLOURED LENS CASE | Nov 02, 2005 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K041820 | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE | Sep 09, 2005 | Substantially Equivalent | CIBA VISION CORPORATION |
| K042578 | I-PROMOTIONS CONTACT LENS CASE | Jan 25, 2005 | Substantially Equivalent | I-PROMOTIONS, INC. |
| K040914 | POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS | May 27, 2004 | Substantially Equivalent | EXERO PRODUCTS, INC. |
| K033656 | SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE | Feb 02, 2004 | Substantially Equivalent | SAUFLON PHARMACEUTICALS, LTD. |
| K032309 | NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY | Dec 04, 2003 | Substantially Equivalent | NOVELENS, INC. |
| K030987 | CONTACT LENS STORAGE CASE | Jun 12, 2003 | Substantially Equivalent | PELICAN PRODUCTS |
| K021248 | ICASE | Sep 24, 2002 | Substantially Equivalent | IKEEPS, INC. |
| K013232 | CYBERCASES BY BAUSCH & LOMB | Nov 20, 2001 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K991206 | BONASSE CONTACT LENS CASE | Jun 06, 2000 | Substantially Equivalent | BONASSE ENT. CO., LTD. |
| K993487 | PARAGON LENS VIAL | Dec 22, 1999 | Substantially Equivalent | PARAGON VISION SCIENCES |
| K993486 | PARAGON LENS CARRIER | Dec 22, 1999 | Substantially Equivalent | PARAGON VISION SCIENCES |
| K974635 | PARAGON LENS CARE | Feb 04, 1998 | Substantially Equivalent | PARAGON VISION SCIENCES |
| K974281 | ALCON CONTACT LENS CASE | Jan 20, 1998 | Substantially Equivalent | ALCON LABORATORIES |
| K971618 | ALCON CONTACT LENS CASE | Jul 14, 1997 | Substantially Equivalent | ALCON LABORATORIES |
| K962512 | BOSTON CONTACT LENS CASE | Jul 12, 1996 | Substantially Equivalent | POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
| K950869 | JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE | Oct 27, 1995 | Substantially Equivalent | JOBAR INTL., INC. |
| K951552 | BOSTON CONTACT LENS CASE | Jun 26, 1995 | Substantially Equivalent | POLYMER TECHNOLOGY CORP. |
| K951182 | RYDER CONTACT LENS CASE MODEL 10670 | May 16, 1995 | Substantially Equivalent | BRADSTREET CLINICAL RESEARCH ASSOC., INC. |
| K951181 | RYDER CONTACT LENS CASE | May 12, 1995 | Substantially Equivalent | BRADSTREET CLINICAL RESEARCH ASSOC., INC. |
| K950878 | MENICON SP VIAL | Apr 07, 1995 | Substantially Equivalent | Hyman, Phelps & McNamara, P.C. |
| K950530 | PRO-TEC-CASE | Apr 07, 1995 | Substantially Equivalent | Hyman, Phelps & McNamara, P.C. |
| K945259 | DATEMINDER CONTACT LENS CASE | Jan 24, 1995 | Substantially Equivalent | BRUCE A. BERKLEY |
| K943921 | RYDER CONTACT LENS CASE | Oct 11, 1994 | Substantially Equivalent | CLINICAL RESEARCH ASSOC. |
| K943183 | CIBA VISION(R) CONTACT LENS CASE | Aug 04, 1994 | Substantially Equivalent | CIBA VISION CORPORATION |
| K931620 | OPTI-FREE CONTACT LENS CASE | Jun 28, 1993 | Substantially Equivalent | ALCON LABORATORIES |
| K923458 | CONTACT LENS CASE | May 12, 1993 | Substantially Equivalent | NOMAX, INC. |
| K920064 | OPTI-LENS CONTACT LENS CASE | Mar 04, 1992 | Substantially Equivalent | RYDER INTL. CORP. |
| K915082 | OPTI-LENS(TM) CONTACT LENS CASE | Jan 13, 1992 | Substantially Equivalent | RYDER INTL. CORP. |
| K901748 | KESTREL LENS CASE (208-12NT POLYSTYRENE) | May 31, 1990 | Substantially Equivalent | KESTREL |
| K900778 | ITEM #272 MAGNIF-EYES CONTACT LENS CASE | Mar 30, 1990 | Substantially Equivalent | MAGNIVISION, INC. |
| K900777 | ITEM #273 CONTACT LENS CASES | Mar 30, 1990 | Substantially Equivalent | MAGNIVISION, INC. |
| K897085 | COMFEES(R) + CON-PAK(TM) LENS CASE | Feb 28, 1990 | Substantially Equivalent | MAGNIVISION, INC. |
| K897084 | CONFEES(R)+ CONTACT LENS HOLDER | Feb 28, 1990 | Substantially Equivalent | MAGNIVISION, INC. |
| K900054 | KESTREL LENS CASE 1543-893S/P-1700-2611 | Jan 30, 1990 | Substantially Equivalent | KESTREL |
| K900053 | KESTREL LENS CASE 731H-893S/P-1700-2611 | Jan 30, 1990 | Substantially Equivalent | KESTREL |
| K895167 | THE OPTIC BOX CONTACT LENS CASE | Jan 22, 1990 | Substantially Equivalent | THE OPTIC BOX CO., LTD. |
| K896685 | BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM | Dec 26, 1989 | Substantially Equivalent | BAUSCH & LOMB, INC. |
| K890533 | ITEM #352/#CS352* CONTACT LENS CASES | Jun 23, 1989 | Substantially Equivalent | MAGNIVISION, INC. |
| K882384 | DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 | Jun 23, 1989 | Substantially Equivalent | MAGNIVISION, INC. |
| K884251 | ALLERGAN LENS CASE | Dec 28, 1988 | Substantially Equivalent | ALLERGAN OPTICAL |
| K873825 | GE LEXAN 144R 112 | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K873824 | RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K873823 | MOBAY (BAYER) MAKROLON 2658 3291 | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K873822 | MOBAY (BAYER) MERLON M-40 (H)F 1112 | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K873821 | GE NORYL 731-80089S | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K873820 | MOBAY (BAYER) MAKROLON 2658 1112 | Mar 24, 1988 | Substantially Equivalent | APPLIED LABORATORIES, INC. |
| K875197 | OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE | Feb 09, 1988 | Substantially Equivalent | PRO-OPTICS, INC. |
| K874657 | RIGID-LENS CASE | Dec 08, 1987 | Substantially Equivalent | SOLA OPHTHALMICS |
| K871741 | EASY EYES TM LENS CARRYING CASE | Jul 22, 1987 | Substantially Equivalent | EATON MEDICAL CORP. |
| K870164 | SUMMIT OPTICS SOFT CONTACT LENS CASE | Feb 10, 1987 | Substantially Equivalent | DAYTON MFG. CO. |
| K853727 | KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) | Feb 07, 1986 | Substantially Equivalent | RYDER INTL. CORP. |
| K840692 | CONTACT LENS CASE FOR SOFT LENSES | Jun 07, 1984 | Substantially Equivalent | OPTIMUM MANUFACTURERS, INC. |
| K840691 | CONTACT LENS CASE FOR RIGID GAS PERMA | May 18, 1984 | Substantially Equivalent | OPTIMUM MANUFACTURERS, INC. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.