OAM001194
OAM001194 is a Class II device made by Quanta System SpA, listed in FDA GUDID since 29 Aug 2016 (UDI-DI 08033945934934), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08033945934934 | Date29 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 08033945934934
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Dermatological laser beam guiding handpiece
- Model / reference
- OAM001194
- Description
- Removable Waveguide 400-1200 nm 48 x13
- Primary DI / UDI-DI
- 08033945934934
- FDA product code
- GEX
- GMDN term
- Dermatological laser beam guiding handpiece
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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