FDA.reportPublic FDA data

510(k) K240095

Device
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
Applicant
Shanghai Care US Medical Product Co., Ltd.
510(k) number
K240095
Product code
LRX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-09
Date received
2024-01-12
Regulation
886.5928
Classification name
Case, Contact Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles Shen
Address
#2, Ln. 10, W. Chenchuan Rd., Baoshan District Shanghai CN 200949 200949

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252175LANDR Contact LENS CaseFourth Axis, LLC2026-02-10
K250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.2025-08-01
K231123Phoenix 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)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.2023-08-30
K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.2017-12-04
K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited2017-11-30
K173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated2017-11-17
K171539Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd2017-07-14
K171163Contact Lens Case Round GlassesFiftytwoways, Ltd.2017-06-27
K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd.2016-12-09
K160005Contact Lens Case (multiple brand name)Danyang Chanxin Glasses Cases Factory2016-06-07
K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens CaseNi Hau Industrial Co., Ltd.2015-05-07
K143351iCase Contact Lens CaseNovabay Pharmaceuticals, Inc.2015-04-29
K140488CONTACT LENS CASEMaca Plastics, Inc.2014-09-10
K131783POLAROID CONTACTSPODViopti, Ltd.2014-02-21
K130930OWL CONTACT LENS CASES, DOG CONTACT LENS CASESNingbo Lishunda Electronics Co., Ltd.2014-02-12