Atlas FDA

Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case

FDA 510(k) clearance K142717 · decided 2015-05-07

Clearance details

K-number
K142717
Device name
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
Applicant
Ni Hau Industrial Co., Ltd.
Decision
Substantially Equivalent
Date received
2014-09-23
Decision date
2015-05-07
Days to decision
226 days
Clearance type
Traditional
Product code
LRX
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Tainan City, TW
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
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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
iCase Contact Lens Case (K143351)Novabay Pharmaceuticals, Inc.2015-04-29

Recalls involving this device

No recalls on record reference this clearance.