# K072331: Radiancy Mistral Device

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Jan 7, 2008 after 140 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 10 generations back to K910422 (1992). 84 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052442: Radiancy Skinstation with Psoriasis Light Unit Assembly, Radiancy (Israel), Ltd. (2006) Summary page 2.
- K051508: Med Flash II Intense Pulsed Light System., General Project S.R.L. (2005) Summary page 2.
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System, Mccue Plc (2006) Summary page 2.

## Most influential descendants
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own
- K220794: 10PL (2022), 0 descendants of its own
- K101901: Ipl Therapy System (2011), 0 descendants of its own

## Indications for use
The Radiancy's Mistral Device is intended to provide phototherapeutic light and heat energy to the body and is generally indicated to treat dermatological conditions. The Mistral is specifically indicated for hair removal and treatment of vascular and pigmented lesions, mild to moderate inflammatory acne vulgaris which includes pustular acne, in patients with Fitzpatrick skin types I - VI, and mild to moderate psoriasis in patients with Fitzpatrick skin types I - VI.

Source page: https://510kreport.com/device/K072331
Methodology: https://510kreport.com/methodology