Identity
- Trade Name
- EASYRET FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases. FDA UDI
- Model / Reference
- EASYRET FDA UDI
- Description
- The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625484 FDA UDI
- 510(k) Number
- K170067 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system 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
Easyret by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic solid-state laser system.
- Eagle — Belkin Vision, Ltd. · Class II
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- 25ga Straight Laser Probe — Vortex Surgical, Inc. · Class II
- Voyager DSLT — Belkin Vision, Ltd. · Class II
- TruScan Pro — Lightmed Corp. · Class II
- Smart-V Illumination Add-on — Lumenis Be, Inc. · Class II
- PASCAL Synthesis, 577nm — Iridex Corporation · Class II
Cleared under the same submission
K170067 also covers:
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
- Quantel Medical
Sources (1)
- FDA UDI 9f4e38e9-129e-4e28-9a8d-6bdd1275ec32 35 fields · synced May 31, 2026