ENTity USB Videoscope System
by Optim LLC
510(k) K254133
ENTity USB Videoscope System is a medical device (FDA Class II; FDA product code EOB, Nasopharyngoscope (Flexible Or Rigid)) made by Optim LLC, cleared under FDA 510(k) K254133 on 14 May 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254133 | Date14 May 2026 | StatusActive |
Official records
- FDA 510(k) database K254133
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EOB
- FDA applicant
- Optim, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 874.4760
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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