SculpSure
FDA 510(k) clearance K160470 · decided 2016-07-21
Clearance details
- K-number
- K160470
- Device name
- SculpSure
- Applicant
- Cynosure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-02-19
- Decision date
- 2016-07-21
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- PKT
- Device class
- 2
- Regulation number
- 878.5400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wesford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cynosure
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 1060nm laser body slimming machine (K240658) | Hebei JT Medical Co., Ltd. | 2024-05-13 |
| ReBorn (1050nm) (K233962) | Lightfective , Ltd. | 2024-04-16 |
| DEKA PHYSIQ 360 (K231971) | El.En S.P.A. | 2023-09-26 |
| Diode Laser Body Sculpture Systems (K231131) | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 |
| EON (K222226) | Dominion Aesthetic Technologies, Inc. | 2023-02-17 |
| Diosculpt (K222265) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 |
| EON (K211681) | Dominion Aesthetic Technologies, Inc. | 2022-03-30 |
| BodySculp (K212331) | Rohrer Aesthetics, LLC | 2021-11-09 |
| Powersculp laser lipolysis system (K211402) | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 |
| SLIMUS (K192970) | Hironic Co., Ltd. | 2020-12-01 |
| Diode Laser Body Sculpture System (K201731) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 |
| Powersculp laser lipolysis system (K191068) | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 |
Recalls involving this device
No recalls on record reference this clearance.