Identity
- Trade Name
- OPTIMIS FUSION FDA UDI
- Generic Name
- Ophthalmic solid-state laser system, photodisruption FDA UDI
- Device Name
- SLT/YAG Laser (Dual-mode laser cavity, 532nm and 1064nm) FDA UDI
- Model / Reference
- OPTIMIS FUSION FDA UDI
- Description
- SLT/YAG Laser (Dual-mode laser cavity, 532nm and 1064nm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625460 FDA UDI
- 510(k) Number
- K140336 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system, photodisruption FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic solid-state laser system, photodisruption
Optimis Fusion by Quantel Medical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic solid-state laser system, photodisruption.
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- PASCAL Synthesis — Topcon Medical Laser Systems, Inc. · Class II
- PASCAL Synthesis — Topcon Medical Laser Systems, Inc. · Class II
- PACSAL Synthesis — Topcon Medical Laser Systems, Inc. · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quantel Medical
Sources (2)
- FDA UDI b15e56ab-63a1-461c-bd23-a0a6a41ce17c 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026