Forma System, Forma Light System
510(k) K160195
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160195 | Date15 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K160195
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- FDA applicant
- Formatk Systems , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Forma System and Forma Light System are powered light based non-laser surgical instruments with thermal effect. They are indicated for use in aesthetic applications in dermatology.
The device is supplied as a system with connection capability for various treatment handpieces to enable multi-application treatment options. It is a Class II device cleared under FDA 510(k) submission K160195 and is intended for use in general and plastic surgery settings.
Devices cleared under K160195
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 | |||
|---|---|---|---|---|
| B-HR FS10006 | FS10006 / FS10006 | 07290016681246 | On the market | |
| B-HR* FS10007 | FS10007 / FS10007 | 07290016681253 | On the market | |
| B-SR FS10008 | FS10008 / FS10008 | 07290016681260 | On the market | |
| F-AC FS10005 | FS10005 / FS10005 | 07290016681239 | On the market | |
| F-HR FS10002 | FS10002 / FS10002 | 07290016681208 | On the market | |
| F-HR* FS10003 | FS10003 / FS10003 | 07290016681215 | On the market | |
| F-SR FS10004 | FS10004 / FS10004 | 07290016681222 | On the market | |
| Forma Cart FS10001 | FS10001 / FS10001 | 07290016681109 | On the market | |
| Forma FS10000 | FS10000 / FS10000 | 07290016681000 | On the market | |
| Forma Light FS60000 | FS60000 / FS60000 | 07290016681017 | On the market | |
| HR FS60002 | FS60002 / FS60002 | 07290016681284 | On the market | |
| HR* FS60003 | FS60003 / FS60003 | 07290016681291 | On the market | |
| iProElite Cart FS10001-3 | FS10001-3 / FS10001-3 | 07290016681147 | On the market | |
| iProElite FS10000-3 | FS10000-3 / FS10000-3 | 07290016681093 | On the market | |
| PLG FS10009 | FS10009 / FS10009 | 07290016681314 | On the market | |
| SR FS60001 | FS60001 / FS60001 | 07290016681307 | On the market | |
| ST FS10011 | FS10011 / FS10011 | 07290016681277 | On the market |
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