# K252561: BTL-754FF

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Feb 18, 2026 after 189 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: 27 generations back to K943450 (1995). 612 ancestors in all.
No later device cites it as a predicate yet.
0 of 613 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241270: BTL-754, BTL Industries, Inc. (2025) Summary page 7.
- K153229: Superbium, Bios S.R.L. (2016) Summary page 7.
- K023734: Aramis II Dermatological Laser, Quantel Medical (2003) Summary page 7.
- K032260: Aramis II Dermatological Laser, Quantel Medical (2003) Summary page 7.
- K150140: MCL 31 Dermablate, Asclepion Laser Technologies GmbH (2015) Summary page 7.
- K233024: Alma Harmony, Alma Lasers, Inc. (2024) Summary page 7.
- K210634: MCL 31 Dermablate System, Asclepion Laser Technologies GmbH (2022) Summary page 18.

## Indications for use
The BTL-754FF device with BTL-754-1 handpiece has the following indications for use: The BTL-754-1 with 2940nm is intended for use in Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: o Acne scars o Wrinkles The BTL-754-1 with 1540nm is intended to be used for incision, excision, ablation, and coagulation (hemostasis) of soft tissue. The device is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), for the treatment of periorbital and perioral wrinkles, for the treatment of back acne. The BTL-754-1 with combined 1540nm and 2940nm is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing, treatment of wrinkles and textural irregularities. BTL-754-4 handpiece has the following indications for use: The BTL-754-4 with 2940nm in Fractional mode 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 BTL-754-4 with 1540nm in Fractional mode 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 BTL-754-4 with combined 1540nm and 2940nm in Fractional mode 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. The BTL-754-4 with 1540nm in Macro mode is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K252561
Methodology: https://510kreport.com/methodology