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Shaser V-Mini RX

by Shaser, Inc.

510(k) K132170

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 · Traditional NumberK132170 Date26 Nov 2013ClearedStatusActive

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  • Withdrawn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
ONF
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 device is a Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, as defined in the device specifications. It is intended for use in general and plastic surgery applications.

The Shaser V-Mini RX is supplied as a cordless, rechargeable system for over-the-counter home use. It utilizes pulsed light energy to target hair follicles for permanent reduction in unwanted hair. The device has received FDA 510(k) clearance under K132170 and is classified as a Class II medical device.

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Questions

AI-generated answers, 27 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 is the SHASER V-MINI RX intended for?

    The SHASER V-MINI RX is intended for use in general and plastic surgery applications as a powered light-based non-laser surgical instrument with thermal effect, utilizing pulsed light energy to target hair follicles for permanent reduction in unwanted hair.

  • How is the SHASER V-MINI RX supplied and powered?

    The SHASER V-MINI RX is supplied as a cordless, rechargeable system designed for over-the-counter home use, meaning it operates without a power cord and is recharged via an internal battery after use.

  • What regulatory clearance does the SHASER V-MINI RX have?

    The SHASER V-MINI RX has received FDA 510(k) clearance under submission number K132170, which confirms it is substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device.