510(k) K171992
- Device
- Sculpsure
- Applicant
- Cynosure, Inc
- 510(k) number
- K171992
- Product code
- PKT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-26
- Date received
- 2017-07-03
- 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
- Amy Tannenbaum
- Address
- 5 Carlisle Rd. Wesford MA US 01886 01886
FDA Registration Numbers#
- 3008915316
- 1222993
- 3013602304
- 3025379728
- 3007712511
- 3026038437
- 3012294783
- 3001431138
- 3007120647
- 3014980461
- 3006515340
- 3021315370
- 3004505220
- 3031944951
- 3026540840
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 |
| K233962 | ReBorn (1050nm) | Lightfective , Ltd. | 2024-04-16 |
| 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 |
| K171111 | Sculpsure | Cynosure, Inc. | 2017-06-13 |
Legacy Summary#
summary
FDA Review#
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