Identity
- Trade Name
- KEN OKUYAMA FDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. FDA UDI
- Model / Reference
- KO-401-1 FDA UDI
- Description
- An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549930092793 FDA UDI
- FDA Product Code
- HQZ FDA UDI
- GMDN Term
- Spectacle frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5842 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spectacle frame
Ken Okuyama by Sunreeve Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spectacle frame.
- Fielmann — Fielmann Group AG · Class I
- BBIG — BBig B.V. · Class I
- Fysh — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- BBIG — BBig B.V. · Class I
- Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
- BBIG — BBig B.V. · Class I
- Fielmann — Fielmann Group AG · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunreeve Co., Ltd.
Sources (1)
- FDA UDI 7c931431-01f4-40ff-89e2-75151ae832df 33 fields · synced Jun 8, 2026