# K083590: Iskra Medical Green Irf Prestige

- Pathway: 510(k) (Traditional)
- Applicant: Iskra Medical, D.O.O.
- Decided: Apr 17, 2009 after 134 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 88 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 1.
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL, Alma Lasers, Ltd. (2007) Summary page 1.
- K033942: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K040135: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K053365: Modification to Thermage Thermacool System, Thermage, Inc. (2005) Summary page 1.
- K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 1.

## Most influential descendants
- K092191: Exilis, Model 5000 (2009), 12 descendants of its own
- K193201: BTL-785F (2020), 8 descendants of its own
- K211639: BTL-785W (2022), 7 descendants of its own
- K222556: BTL-785X (2023), 5 descendants of its own
- K233604: BTL-785S (2024), 3 descendants of its own

## Indications for use
Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.

Source page: https://510kreport.com/device/K083590
Methodology: https://510kreport.com/methodology