Who else makes this device?

Name: Deep Well Lens Case (Smooth
Brand: Deep Well Lens Case (Smooth

Ophthalmic › TherapeuticCase, Contact Lens

Deep Well Lens Case (Smooth

Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a smooth lens well surface. They are used for the storage and chemical disinfection of hard, GP or…

Registry build 21.09.26

Deep Well Lens Cases are fabricated from a low-density polyethylene plastic resin and have a smooth lens well surface. They are used for the storage and chemical disinfection of hard, GP or soft contact lenses. They are not to be used with heat disinfection.

6manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (2), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LRX
Manufacturer	City	Province	Registered as	Device types
Shun SZE Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	22
China (Shenyang) MED-Land IMP/EXP Corp., Ltd.	Shanghai	Shanghai	Exporter	32
Shanghai Care Us Medical Product Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	30
Action Eyewear Corp.	Dong Guan	Guangdong	Contract manufacturer	5
Ningbo Kaida Rubber AND Plastic Technology Co., Ltd.	Yu Yao City, Zhejiang Province		Contract manufacturer	2
Danyang Chanxin Glasses Cases Factory	Danyang	Jiangsu	Manufacturer	1

Record

Regulatory record for Deep Well Lens Case (Smooth
Listed by	Paragon Vision Sciences, Inc., United States
FDA product code	LRX
Device type	Case, Contact Lens
Device class	Class 2
Regulation	21 CFR 886.5928
Establishment	Complaint-file establishment, Manufacturer
Record published	2017-12-08
Record revised	2021-03-23 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Deep Well Lens Case (Smooth
Catalogue number	Size	Per pack	Status
500		500	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Optisource	Phoenix Medical Solutions	18
Bonasse	Bonasse Enterprises Co., Ltd.	12
Equate	Wal Mart Stores, Inc	11
Optego	Optego Vision USA, Inc.	10
UP & UP	Target Health, Inc.	7
Meijer	Meijer, Inc.	6
Flents	Apothecary Products, LLC.	6
Jingsheng	Ningbo Haishu Jingsheng Plastic Co., Ltd.	4
Bausch + Lomb	Bausch & Lomb Incorporated	4
Apex	Drive DeVilbiss Healthcare	3
Color Case	Watchdog Group, LC	3
Phoenix Healthcare Solutions LLC	Phoenix Medical Solutions	3

Showing 12 of 52. All products under Case, Contact Lens

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K993487	1999-12-22
K993486	1999-12-22
K974635	1998-02-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.