Enlight 2100 (TPL-E2103-0)
FDA 510(k) clearance K250464 · decided 2025-09-10
Clearance details
- K-number
- K250464
- Device name
- Enlight 2100 (TPL-E2103-0)
- Applicant
- Timpel S.A.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-18
- Decision date
- 2025-09-10
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- QEB
- Device class
- 2
- Regulation number
- 868.1505
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- São Paulo, BR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LuMon(TM) System (K243765) | Sentec AG | 2025-08-07 |
| AirTom (K222466) | Bilab | 2023-06-30 |
| Enlight 2100 (K222897) | Timpel S.A. | 2023-03-07 |
| Enlight 2100 (K211135) | Timpel S.A. | 2022-01-06 |
| Enlight 1810 (DEN170072) | Timpel, Inc. | 2018-12-20 |
Recalls involving this device
No recalls on record reference this clearance.