Pls Portable Light Source
by Optim, Inc.
510(k) K091829
Pls Portable Light Source is a Class II device made by Optim, Inc., cleared under FDA 510(k) K091829 on 28 Jul 2009, 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 | NumberK091829 | Date28 Jul 2009 | StatusActive |
Official records
- FDA 510(k) database K091829
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NTN
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K091829
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Portable Light Source F0063873L1 | F0063873L1 | 00858119004101 | — | On the market |
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Other devices filed under FDA product code NTN (Led Light Source).
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