FDA.reportPublic FDA data

510(k) K251876

Device
cleadew GP hydra one
Applicant
Ophtecs Corporation
510(k) number
K251876
Product code
MRC
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-09
Date received
2025-06-18
Regulation
886.5918
Classification name
Products, Contact Lens Care, Rigid Gas Permeable
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Takeichi Ryohei
Address
5-2-4, Minatojima-Minamimachi, Chuo-Ku, Kobe JP 650-0047 650-0047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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