Identity
- Trade Name
- 577nm Heine Omega 500 IO with integrated adaptor FDA UDI
- Generic Name
- Indirect binocular laser ophthalmoscope FDA UDI
- Device Name
- 577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor FDA UDI
- Model / Reference
- IOH577 FDA UDI
- Description
- 577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625392 FDA UDI
- 510(k) Number
- K091581 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Indirect binocular laser ophthalmoscope 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: Indirect binocular laser ophthalmoscope
577nm Heine Omega 500 IO with integrated adaptor by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indirect binocular laser ophthalmoscope.
- TruFocus LIO Premiere — Iridex Corporation · Class II
- PASCAL Laser Indirect Ophthalmoscope — Topcon Medical Laser Systems, Inc. · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- TruFocus LIO Premiere — Iridex Corporation · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- PASCAL Laser Indirect Ophthalmoscope — Topcon Medical Laser Systems, Inc. · Class II
- Norlase LION photocoagulator — Norlase Aps · Class II
- PASCAL Laser Indirect Ophthalmoscope — Topcon Medical Laser Systems, Inc. · Class II
Cleared under the same submission
K091581 also covers:
- 577nm adaptor for HS900 BM/BQ Slit Lamp — QUANTEL MEDICAL
- 577nm adaptor for Keeler Vantage Plus IO (100µ) — QUANTEL MEDICAL
- 577nm adaptor for ZEISS 120 Slit Lamp — QUANTEL MEDICAL
- 577nm adaptor for ZEISS 130 Slit Lamp — QUANTEL MEDICAL
- 577nm adaptor for ZEISS 30 Slit Lamp — QUANTEL MEDICAL
- SUPRA 577Y — QUANTEL MEDICAL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantel Medical
Sources (1)
- FDA UDI 3f0f2079-892e-4a49-9692-9b34e0070152 35 fields · synced May 29, 2026