Identity
- Trade Name
- 577nm adaptor for HS900 BM/BQ Slit Lamp FDA UDI
- Generic Name
- Laser adaptor FDA UDI
- Device Name
- Fold away 577nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot) FDA UDI
- Model / Reference
- 577HSD FDA UDI
- Description
- Fold away 577nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625354 FDA UDI
- 510(k) Number
- K091581 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Laser adaptor 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: Laser adaptor
577nm adaptor for HS900 BM/BQ Slit Lamp by Quantel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091581 also covers:
- 577nm Heine Omega 500 IO with integrated adaptor — 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 792dfce8-6b47-49d9-9628-dc09c6527fe3 35 fields · synced May 31, 2026