Cleadew GP Hydra One

cleadew GP hydra one is a multipurpose care solution for fluoro silicone acrylate and silicone acrylate rigid gas-permeable contact lenses. It is used for cleaning, protein removal,…

Registry build 21.09.26

cleadew GP hydra one is a multipurpose care solution for fluoro silicone acrylate and silicone acrylate rigid gas-permeable contact lenses. It is used for cleaning, protein removal, rinsing, disinfection, conditioning and storage.

The sterile buffered aqueous formulation includes sodium hyaluronate and hypromellose, together with other salts and formulation ingredients. It is preserved with 0.004% hydrogen peroxide and 0.0005% polyhexamethylene biguanide hydrochloride.

Bottle Formats

The solution is supplied in 60 mL and 360 mL multidose bottles with tamper-resistant packaging. The specified lens materials define its intended compatibility.

1manufacturer
2catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code MRC
Manufacturer City Province Registered as Device types
AMO (Hangzhou) Co., Ltd. Hangzhou Zhejiang Manufacturer 2

Record

Regulatory record for cleadew GP hydra one
Listed by Ophtecs Corporation, Japan
FDA product code MRC
Device type Products, Contact Lens Care, Rigid Gas Permeable
Device class Class 2
Regulation 21 CFR 886.5918
510(k) K251876
Record published 2026-05-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Over the counter Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for cleadew GP hydra one
Catalogue number Size Status
60 mL In distribution
360 mL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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up & up rigid gas permeable contact lens conditioning solution Target Health, Inc. 1
Tangible Fill DRY EYE Innovations, LLC 1

Showing 12 of 18. All products under Products, Contact Lens Care, Rigid Gas Permeable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251876 2025-10-09

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer