BTL-754FF— 510(k) K252561
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K252561 for BTL-754FF, Substantially Equivalent on 2026-02-18. Applicant: BTL Industries, Inc.. Device class: 2.
Summary
BTL Industries filed a device named only BTL-754FF under product code GEX, powered laser surgical instrument. The record doesn't describe it beyond that name and code name.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
BTL Industries filed from Marlborough, Massachusetts. Review took 189 calendar days (August 13, 2025 to February 18, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code GEX
view allMore clearances from BTL Industries, Inc.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.