510(k) K233962
- Device
- ReBorn (1050nm)
- Applicant
- Lightfective , Ltd.
- 510(k) number
- K233962
- Product code
- PKT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-16
- Date received
- 2023-12-15
- Regulation
- 878.5400
- Classification name
- Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tsvi Bahat
- Address
- 2 Hatochen St. Caesarea IL 3079533 3079533
FDA Registration Numbers#
- 1222993
- 3026540840
- 3007712511
- 3012294783
- 3001431138
- 3008915316
- 3014980461
- 3004505220
- 3025379728
- 3007120647
- 3026038437
- 3027619554
- 3042351542
- 3013602304
- 3031944951
- 3006515340
- 3021315370
Source Documents#
Other 510(k) Records For Product Code PKT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | 2024-05-13 |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | 2023-09-26 |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 |
| K222226 | EON | Dominion Aesthetic Technologies, Inc. | 2023-02-17 |
| K222265 | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 |
| K211681 | EON | Dominion Aesthetic Technologies, Inc. | 2022-03-30 |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | 2021-11-09 |
| K211402 | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 |
| K192970 | SLIMUS | Hironic Co., Ltd. | 2020-12-01 |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 |
| K180511 | Eon FR | Dominion Aesthetic Technologies, Inc. | 2019-06-12 |
| K182741 | SculpSure | Cynosure | 2019-01-03 |
| K171992 | SculpSure | Cynosure, Inc. | 2017-09-26 |
| K171111 | Sculpsure | Cynosure, Inc. | 2017-06-13 |