Forma System, Forma Light System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160195 FDA 510(k)
- FDA Product Code
- ONF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the Forma System and Forma Light System used for?
The Forma System and Forma Light System are powered light based non-laser surgical instruments with thermal effect, indicated for use in aesthetic applications in dermatology, as stated in the device description.
How is the Forma System supplied and what components does it include?
The device is supplied as a system with connection capability for various treatment handpieces to enable multi-application treatment options, allowing for flexible configuration based on clinical needs.
Is the Forma System a single-use or reusable device?
The device data does not specify whether the Forma System or its handpieces are single-use or reusable; therefore, reuse status cannot be determined from the provided information.
What regulatory pathway was used for the Forma System?
The Forma System was cleared under the FDA 510(k) pathway, specifically submission K160195, and is classified as a Class II device.
In what clinical settings is the Forma System intended to be used?
The device is intended for use in general and plastic surgery settings, as indicated in the device description and supported by the advisory committee designation for General, Plastic Surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Formatk, Forma System, Forma Light System (K160195) — FDA 510 (k) | Innolitics, Forma System - Formatk
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160195 | Class II | Active |
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Manufacturer
- Manufacturer
- Formatk Systems Ltd
- FDA Applicant
- Formatk Systems , Ltd.
Sources (1)
- FDA 510(k) K160195 24 fields · synced Sep 26, 2026