Atlas FDA

ALCON CONTACT LENS CASE

FDA 510(k) clearance K971618 · decided 1997-07-14

Clearance details

K-number
K971618
Device name
ALCON CONTACT LENS CASE
Applicant
Alcon Laboratories
Decision
Substantially Equivalent
Date received
1997-05-02
Decision date
1997-07-14
Days to decision
73 days
Clearance type
Traditional
Product code
LRX
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17