# K150051: Exilite

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Apr 8, 2015 after 86 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: 12 generations back to K910422 (1992). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122995: Intense Pulsed Light (Ipl) Systems, Beijing Kes Biology Technology Co., Ltd. (2013) Summary page 4.

## Indications for use
Exilite system (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in reduction of pigmented lesions, acne therapy, freckle, vascular lesions, facial blemish removal, and permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Source page: https://510kreport.com/device/K150051
Methodology: https://510kreport.com/methodology