Identity
- Trade Name
- OPSoft® Mouthguards for laser (10 units) FDA UDI
- Generic Name
- Laser protective mouthguard FDA UDI
- Device Name
- The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, and perioral procedures with laser, IPL or RF. FDA UDI
- Model / Reference
- 60-104 FDA UDI
- Description
- The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, and perioral procedures with laser, IPL or RF. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20697660004864 FDA UDI
- FDA Product Code
- BRW FDA UDI
- GMDN Term
- Laser protective mouthguard FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 4.5 Centimeter FDA UDILength — 12 Centimeter FDA UDI
Category: Laser protective mouthguard
OPSoft® Mouthguards for laser (10 units) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser protective mouthguard.
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 |
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Manufacturer
- Manufacturer
- Oculo-Plastik Inc
Sources (1)
- FDA UDI c2f7becc-ec61-41e4-ad2e-491ab621aad0 35 fields · synced May 30, 2026