Identity
- Trade Name
- O35 FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Customized product FDA UDI
- Model / Reference
- HH066000 FDA UDI
- Description
- Customized product FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051272100334 FDA UDI
- 510(k) Number
- K163449 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical solid-state laser system
O35 by Hyper Photonics Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical solid-state laser system.
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- DEKA LIPOAI — EL.EN. SPA · Class II
- SOLTIVE — Gyrus Acmi, Inc. · Class II
- Thuvera — IPG Medical Corporation · Class II
- ACCENTO — Bison Medical Co, Ltd. · Class II
- Lumenis Pulse 60H — Lumenis · Class II
Cleared under the same submission
K163449 also covers:
- MultiPulse Ho — Asclepion Laser Technologies GmbH
- HYPHO — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Re-Usable surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
- Single use surgical optical fiber — HYPER PHOTONICS SRL
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hyper Photonics Srl
Sources (1)
- FDA UDI b3381f09-d03f-45b0-b47f-eb022b913c40 34 fields · synced May 30, 2026