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Legacy BX

by Venus Concept USA, Inc.

510(k) K142910

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK142910 Date19 Dec 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Legacy BX is an electrosurgical device classified under Electrosurgical, Cutting & Coagulation & Accessories (Product Code: GEI), designed for non-invasive dermatologic and general surgical procedures. It employs controlled energy delivery to address moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I–IV, providing tissue treatment through precise coagulation and cutting mechanisms.

Intended for use in clinical settings, the Legacy BX is supplied as a reusable device and requires proper sterilization between procedures. It is not MRI-safe and must be used in accordance with manufacturer guidelines to ensure safety and efficacy. Authorized under FDA 510(k) clearance (K142910) with a decision of Substantially Equivalent (SESE), it falls under the regulatory classification for general and plastic surgery applications.

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See all devices from Venus Concept USA, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of skin conditions or cosmetic procedures is the Legacy BX designed to treat?

    The Legacy BX is specifically designed for non-invasive dermatologic and general surgical procedures to address moderate to severe facial wrinkles and rhytides. It uses controlled energy delivery to treat Fitzpatrick skin types I–IV through precise coagulation and cutting mechanisms, making it suitable for cosmetic skin rejuvenation in clinical settings.

  • Is the Legacy BX a single-use device, or can it be reused after sterilization?

    The Legacy BX is a reusable device, meaning it is intended to be sterilized between uses in clinical settings. Proper sterilization is required to maintain safety and functionality, as outlined in the manufacturer’s guidelines.

  • How is the Legacy BX regulated, and what does its FDA clearance status mean?

    The Legacy BX holds an FDA 510(k) clearance (K142910) under the classification for Electrosurgical, Cutting & Coagulation & Accessories (Product Code: GEI). The clearance is marked as ‘Substantially Equivalent (SESE),’ indicating the device meets regulatory standards for general and plastic surgery applications as determined by the FDA’s review process.

  • Can the Legacy BX be used in an MRI environment, or are there any safety concerns?

    The Legacy BX is explicitly not MRI-safe. It must be used in non-MRI environments, and clinicians should follow the manufacturer’s safety guidelines to avoid risks associated with electromagnetic interference or other hazards in MRI settings.

  • Who should I contact if I need more information about the Legacy BX’s specifications or usage?

    For inquiries regarding the Legacy BX, you may reach out to Venus Concept USA, Inc. at their contact address: 4556 N. Hiatus Rd., Sunrise, FL 33351. The primary contact listed is Lilia Schlosberg, though you may verify current contact details through the manufacturer’s official channels.