# K241270: BTL-754

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Jan 30, 2025 after 269 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: 18 generations back to K910422 (1992). 252 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142376: Palomar Icon Aesthetic System, Cynosure, Inc. (2014) Summary page 6.

## Most influential descendants
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The BTL-754 device with BTL-754-4 handpiece has the following indications for use: The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. The combined 1540nm and 2940nm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

Source page: https://510kreport.com/device/K241270
Methodology: https://510kreport.com/methodology