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BTL-754

BTL Industries, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

Summary PDF

Company

BTL Industries, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K241270
Device name
BTL-754
Company
BTL Industries, Inc.
Country / Region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-05-06
Decision date
2025-01-30
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Skin resurfacingPigment treatmentVascular treatmentAcne treatment
Primary application
Skin resurfacing
Classification source
AI classified

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.

Intended 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.

Device Description

The BTL-754 device and the predicates are comprised of a system console and applicators.

Summary parsed at:2026-06-01 05:21:04 UTC

Predicate devices

1

K241270 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K241270 as a predicate