# K160195: Forma System, Forma Light System

- Pathway: 510(k) (Traditional)
- Applicant: Formatk Systems, Ltd.
- Decided: Apr 15, 2016 after 79 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K910422 (1992). 340 ancestors in all.
No later device cites it as a predicate yet.
0 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090221: Reaction System, Viora, Ltd. (2009) Summary page 6.
- K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 6.

## Indications for use
The Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology. The Forma System and Forma Light System** have connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1) The Forma System and Forma Light System** with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm are indicated for: HR*, F-HR*, B-HR* Applicators (650-1100nm): * Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction® in skin types I-V through selective targeting of melanin in hair follicles. HR, F-HR, B-HR Applicators (590-1100nm): * Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles. SR, F-SR, B-SR Applicators (530-1100nm): * Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) * Cutaneous lesions, including striae * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. F-AC Applicator (430-1100nm): * Mild to moderate inflammatory Acne (Acne vulgaris) 2) The Forma System with the ST Handpiece (Radio Frequency) is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. 3) The Forma System with the PLG Handpiece (Microdermabrasion Applicator) is indicated for skin dermabrasion. Notes: * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. ** The Forma Light System is a desktop model of the Forma System and is based on IPL technology only.

Source page: https://510kreport.com/device/K160195
Methodology: https://510kreport.com/methodology