Darwin
by Luvo Medical Technologies Inc 2 variants
510(k) K203728
Darwin is a Class II device made by Luvo Medical Technologies Inc, cleared under FDA 510(k) K203728 on 14 Jul 2021, 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 | NumberK203728 | Date14 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K203728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Luvo Medical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203728
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 | |||
|---|---|---|---|---|
| Darwin Diode Laser Handpiece 9300-A0000101LV | 9300-A0000101LV | 00754016214165 | — | On the market |
| Darwin ESK-3272LV | ESK-3272LV | 00754016214134 | — | On the market |
| Darwin IPL Handpiece 3134 A9999001LV | 3134 A9999001LV | 00754016214158 | — | On the market |
| RF Microneedling Handpiece 3245-A9900201LV | 3245-A9900201LV | 00754016214172 | — | On the market |
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