OralID FS-11
by Forward Science Technologies LLC
OralID FS-11 is a Class II device made by Forward Science Technologies LLC, cleared under FDA 510(k) K123169 on 13 Mar 2013 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 00370275123163), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00370275123163 | Date3 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123169 | Date13 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 00370275123163
- FDA 510(k) database K123169
Across registries
- FDA 510(k) K123169 decided 13 Mar 2013 Active
- FDA GUDID UDI-DI 00370275123163 listed 3 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K123169
- Listed FDA GUDID 00370275123163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OralID
- Generic name
- Oral lesion examination light
- Model / reference
- FS-11
- Primary DI / UDI-DI
- 00370275123163
- 510(k) Number
- FDA product code
- NXV
- GMDN term
- Oral lesion examination light
- Device class
- Class II
- Regulation number
- 872.6350
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).
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- TRIMIRA OCS 3000 by Remicalm, LLC
- ORALID by Forward Science, LLC