FDA.report

510(k) K253750

Device
BTL-785NEH
Applicant
BTL Industries, Inc.
510(k) number
K253750
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-17
Date received
2025-11-25
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
David Chmel
Address
362 Elm St. Marlborough MA US 01752 01752

FDA Registration Numbers

Source Documents

510(k) summary PDF

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