IPL + Diode Laser Machine
by Beijing Globalipl Development Co., Ltd.
510(k) K193328
IPL + Diode Laser Machine is a medical device (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Beijing Globalipl Development Co., Ltd., cleared under FDA 510(k) K193328 on 25 Mar 2020, active as of 22 Oct 2026.
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193328 | Date25 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K193328
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193328
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 | |||
|---|---|---|---|---|
| Globalipl US419 | US419 | 06973494934196 | — | On the market |
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