BTL Industries, Inc.

Country / region:United States (US)

510(k) submissions

2

Latest clearance

2026-02-18

Product codes

1

GEX

Cited as predicate

1

Product areas

FDA product code distribution

510(k) submissions

2 total

K number	Device name	Product code	Class	Decision date
K252561	BTL-754FF	GEX	Class 2	2026-02-18
K241270	BTL-754	GEX	Class 2	2025-01-30

Company profile

Canonical name: BTL Industries, Inc.
Country: United States(US)

Cited predicates

8

K023734
—
—
Not ingested
K032260
—
—
Not ingested
K150140
MCL 31 Dermablate
Asclepion Laser Technologies GmbH
K153229
Superbium
Bios S.R.L.
K210634
MCL 31 Dermablate System
Asclepion Laser Technologies GmbH
K233024
Alma Harmony
Alma Lasers, Inc.
K241270
BTL-754
BTL Industries, Inc.
K142376
—
—
Not ingested

BTL Industries, Inc. references 8 predicate/reference devices

Cited as predicate

1

K252561
BTL-754FF
BTL Industries, Inc.

1 submission cite BTL Industries, Inc. as a predicate