Atlas FDA

LRX

82 FDA 510(k) clearances · Product code

76 daysmedian time to decision
245 days90th percentile
82clearances measured

FDA profile

Official device name
Case, Contact Lens
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5928
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1998: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LANDR Contact LENS Case (K252175)Fourth Axis, LLC2026-02-10
MINI VP1 (PL67_F); MINI VP1 (PL61_F) (K250495)Avizor S.A.2025-08-01
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (K240095)Shanghai Care US Medical Product Co., Ltd.2024-10-09
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) (K231123)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.2023-08-30
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K173538)Alcon Laboratories, Inc.2017-12-04
Contact Lens Case, Model: A-1, B-1 (K172925)P L Overseas Limited2017-11-30
Bausch + Lomb Boston Scleral Lens Case (K173365)Bausch & Lomb, Incorporated2017-11-17
Contact Lens Case (K171539)E-Link Plastic & Metal Industrial Co.,Ltd2017-07-14
Contact Lens Case Round Glasses (K171163)Fiftytwoways, Ltd.2017-06-27
Contact Lens Case (K162869)Ningbo Yinzhou Zonghai Artware Co., Ltd.2016-12-09
Contact Lens Case (multiple brand name) (K160005)Danyang Chanxin Glasses Cases Factory2016-06-07
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case (K142717)Ni Hau Industrial Co., Ltd.2015-05-07
iCase Contact Lens Case (K143351)Novabay Pharmaceuticals, Inc.2015-04-29
CONTACT LENS CASE (K140488)Maca Plastics, Inc.2014-09-10
POLAROID CONTACTSPOD (K131783)Viopti, Ltd.2014-02-21
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES (K130930)Ningbo Lishunda Electronics Co., Ltd.2014-02-12
MENICON NECT CONTACT LENS CASE (K131875)Foresight Regulatory Strategies2013-08-06
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE (K130753)Watchdog Group, LC2013-06-13
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES (K122700)Prosben, Inc.2013-05-31
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS (K130285)The Lagado Corp.2013-04-03
POLARIS DIAL-A-DATE CONTACT LENS CASE (K120904)Reliance Design & Manufacture Corp.2012-11-26
AC LENS BRANDED CONTACT LENS CASE (K120969)Arlington Contact Lens Services,Inc.2012-07-11
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE (K121030)Sacks Holdings, Inc.2012-07-06
EYE CARE CURE CONTACT LENS CASE (K112832)Eye Care and Cure2011-12-05
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE (K111856)Apothecary Products, Inc.2011-07-14
POLARIS CONTACT LENS CASE (K093377)Reliance Design & Manufacturing Corp.2010-04-27
IMAG, IPOD, EZ-FIND AND ISLIDE (K090362)Voguestrap2009-02-27
CONTACT LENS CASE (K071081)Ningbo Kaida Rubber and Plastic Technology Co., LT2007-05-01
SAUFLON FLAT COLOURED LENS CASE (K052809)Sauflon Pharmaceuticals, Ltd.2005-11-02
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (K041820)Ciba Vision Corporation2005-09-09
I-PROMOTIONS CONTACT LENS CASE (K042578)I-Promotions, Inc.2005-01-25
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS (K040914)Exero Products, Inc.2004-05-27
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (K033656)Sauflon Pharmaceuticals, Ltd.2004-02-02
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY (K032309)Novelens, Inc.2003-12-04
CONTACT LENS STORAGE CASE (K030987)Pelican Products2003-06-12
ICASE (K021248)Ikeeps, Inc.2002-09-24
CYBERCASES BY BAUSCH & LOMB (K013232)Bausch & Lomb, Inc.2001-11-20
BONASSE CONTACT LENS CASE (K991206)Bonasse Ent. Co., Ltd.2000-06-06
PARAGON LENS VIAL (K993487)Paragon Vision Sciences1999-12-22
PARAGON LENS CARRIER (K993486)Paragon Vision Sciences1999-12-22
PARAGON LENS CARE (K974635)Paragon Vision Sciences1998-02-04
ALCON CONTACT LENS CASE (K974281)Alcon Laboratories1998-01-20
ALCON CONTACT LENS CASE (K971618)Alcon Laboratories1997-07-14
BOSTON CONTACT LENS CASE (K962512)Polymer Technology Div. Wilmington Partners, L.P.1996-07-12
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE (K950869)Jobar Intl., Inc.1995-10-27
BOSTON CONTACT LENS CASE (K951552)Polymer Technology Corp.1995-06-26
RYDER CONTACT LENS CASE MODEL 10670 (K951182)Bradstreet Clinical Research Assoc., Inc.1995-05-16
RYDER CONTACT LENS CASE (K951181)Bradstreet Clinical Research Assoc., Inc.1995-05-12
MENICON SP VIAL (K950878)Hyman, Phelps & McNamara, P.C.1995-04-07
PRO-TEC-CASE (K950530)Hyman, Phelps & McNamara, P.C.1995-04-07
DATEMINDER CONTACT LENS CASE (K945259)Bruce A. Berkley1995-01-24
RYDER CONTACT LENS CASE (K943921)Clinical Research Assoc.1994-10-11
CIBA VISION(R) CONTACT LENS CASE (K943183)Ciba Vision Corporation1994-08-04
OPTI-FREE CONTACT LENS CASE (K931620)Alcon Laboratories1993-06-28
CONTACT LENS CASE (K923458)Nomax, Inc.1993-05-12
OPTI-LENS CONTACT LENS CASE (K920064)Ryder Intl. Corp.1992-03-04
OPTI-LENS(TM) CONTACT LENS CASE (K915082)Ryder Intl. Corp.1992-01-13
KESTREL LENS CASE (208-12NT POLYSTYRENE) (K901748)Kestrel1990-05-31
ITEM #273 CONTACT LENS CASES (K900777)Magnivision, Inc.1990-03-30
ITEM #272 MAGNIF-EYES CONTACT LENS CASE (K900778)Magnivision, Inc.1990-03-30
COMFEES(R) + CON-PAK(TM) LENS CASE (K897085)Magnivision, Inc.1990-02-28
CONFEES(R)+ CONTACT LENS HOLDER (K897084)Magnivision, Inc.1990-02-28
KESTREL LENS CASE 731H-893S/P-1700-2611 (K900053)Kestrel1990-01-30
KESTREL LENS CASE 1543-893S/P-1700-2611 (K900054)Kestrel1990-01-30
THE OPTIC BOX CONTACT LENS CASE (K895167)The Optic Box Co., Ltd.1990-01-22
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM (K896685)Bausch & Lomb, Inc.1989-12-26
DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 (K882384)Magnivision, Inc.1989-06-23
ITEM #352/#CS352* CONTACT LENS CASES (K890533)Magnivision, Inc.1989-06-23
ALLERGAN LENS CASE (K884251)Allergan Optical1988-12-28
RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 (K873824)Applied Laboratories, Inc.1988-03-24
MOBAY (BAYER) MAKROLON 2658 3291 (K873823)Applied Laboratories, Inc.1988-03-24
MOBAY (BAYER) MAKROLON 2658 1112 (K873820)Applied Laboratories, Inc.1988-03-24
GE LEXAN 144R 112 (K873825)Applied Laboratories, Inc.1988-03-24
GE NORYL 731-80089S (K873821)Applied Laboratories, Inc.1988-03-24
MOBAY (BAYER) MERLON M-40 (H)F 1112 (K873822)Applied Laboratories, Inc.1988-03-24
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE (K875197)Pro-Optics, Inc.1988-02-09
RIGID-LENS CASE (K874657)Sola Ophthalmics1987-12-08
EASY EYES TM LENS CARRYING CASE (K871741)Eaton Medical Corp.1987-07-22
SUMMIT OPTICS SOFT CONTACT LENS CASE (K870164)Dayton Mfg. Co.1987-02-10
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (K853727)Ryder Intl. Corp.1986-02-07
CONTACT LENS CASE FOR SOFT LENSES (K840692)Optimum Manufacturers, Inc.1984-06-07
CONTACT LENS CASE FOR RIGID GAS PERMA (K840691)Optimum Manufacturers, Inc.1984-05-18

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