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Mini Me

by Iluminage Ltd.(Formerly Syneron Beauty Ltd.)

510(k) K143339

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 NumberK143339 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  • Withdrawn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
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, 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 Mini Me is a Powered Light-Based Non-Laser Surgical Instrument with Thermal Effect, classified as a Class II device under FDA regulations. It employs controlled light energy to target and reduce unwanted hair growth through a thermal mechanism, designed for non-invasive cosmetic procedures.

This device is supplied as a reusable medical instrument, intended for use in clinical settings by trained professionals. It is not sterile upon packaging and requires appropriate cleaning and maintenance between uses. The Mini Me is authorized under FDA 510(k) clearance (K143339) for general plastic surgery applications, adhering to regulatory standards for powered light-based devices.

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 is the Mini Me primarily used for in clinical settings?

    The Mini Me is a powered light-based non-laser surgical instrument designed to target and reduce unwanted hair growth through a thermal mechanism. It is intended for non-invasive cosmetic procedures, specifically within the scope of general plastic surgery applications, as authorized by its FDA 510(k) clearance.

  • Is the Mini Me a single-use or reusable device, and what does that mean for maintenance?

    The Mini Me is a reusable medical instrument, meaning it is designed for multiple uses in clinical settings. Since it is not sterile upon packaging, it requires thorough cleaning and maintenance between uses to ensure proper functionality and infection control.

  • How is the Mini Me regulated, and what does its classification mean for purchasing or use?

    The Mini Me is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K143339) for general plastic surgery applications. This classification indicates it has undergone regulatory review to ensure safety and effectiveness, but it does not require pre-market approval like higher-risk devices. The device is authorized for use in clinical settings by trained professionals.

  • What are the key details about the regulatory submission and approval process for the Mini Me?

    The Mini Me was submitted to the FDA under a 510(k) pathway, specifically classified as a 'Special' clearance type, and was determined to be substantially equivalent to a predicate device. The submission was reviewed by the Skin and Soft Tissue (SU) Advisory Committee under the General, Plastic Surgery specialty category, with a decision date of December 19, 2014. The product code (ONF) and regulation number (878.4810) further define its regulatory classification.