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Miin

by Medico USA, Inc.

510(k) K193266

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 NumberK193266 Date22 Jan 2021ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 25 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 Miin is a Q-Switched Nd: YAG Laser Therapy System, indicated for use in incision, excision, ablation, vaporization of soft tissue for general dermatologic and general surgical procedures for coagulation and hemostasis. It operates at 1064nm or 532nm and has four laser modes. The device is used for the treatment of pigmented skin lesions, including melasma, freckles, age spots, and unwanted tattoos, as well as for pore reduction and acne scar treatment using the MLA handpiece.

The Miin is supplied by Medico USA, Inc. and has received FDA 510K clearance, with the reference number K193266. The device is intended for use in general dermatologic and general surgical procedures, and its regulatory status is Substantially Equivalent. The Miin is available with specific product codes and is distributed by Medico USA, Inc.

Questions

AI-generated answers, 25 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 Miin laser used for?

    The Miin laser is used for general dermatologic and general surgical procedures, including treatment of pigmented skin lesions, pore reduction, and acne scar treatment.

  • What are the operating wavelengths of the Miin laser?

    The Miin laser operates at 1064nm or 532nm, with four laser modes available.

  • Is the Miin laser supplied sterile?

    The description does not specify if the Miin laser is supplied sterile, but it is intended for use in surgical procedures, so proper sterilization is likely required.

  • What is the regulatory status of the Miin laser?

    The Miin laser has received FDA 510K clearance, with a reference number of K193266, and is considered Substantially Equivalent.