Identity
- Trade Name
- Symmetry Olsen FDA UDI
- Generic Name
- Laser beam eye protector, patient FDA UDI
- Model / Reference
- 607000 FDA UDI
Identifiers
- Catalog Number
- 607000 FDA UDI
- Primary DI / UDI-DI
- 00841785107702 FDA UDI
- 510(k) Number
- K852404 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Laser beam eye protector, patient FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laser beam eye protector, patient
Symmetry Olsen by Olsen Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser beam eye protector, patient.
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- Doctor Smile / Doctor Diode Laser — LAMBDA SPA · Class I
- Safety Filter 532 nm Topcon OMS 300/320 — Iridex Corporation · Class II
- Doctor Smile / Doctor Diode Laser — LAMBDA SPA · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olsen Medical
Sources (1)
- FDA UDI e4e9fe38-e8cd-4a59-9805-88617f3eafd6 34 fields · synced May 30, 2026