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Lovely System

by Msq (M2), Ltd.

510(k) K033946

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 NumberK033946 Date5 Apr 2004ClearedStatusActive

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  • Withdrawn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
FTC
FDA applicant
Msq (M2) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Lovely System is a Light, Ultraviolet, Dermatological device. It is classified as a General, Plastic Surgery device. The device is substantially equivalent and has a product code of FTC.

The Lovely System is supplied with a 510(k) number of K033946 and is regulated under 21 CFR 878.4630. It has an FDA 510(k) clearance and is used in medical specialties such as General and Plastic Surgery. The device has a registration number and is classified as a class 2 device.

Other devices from Msq (M2), Ltd.

Questions

AI-generated answers, 24 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 Lovely System used for?

    The Lovely System is used in medical specialties such as General and Plastic Surgery, utilizing ultraviolet light for dermatological purposes.

  • Is the Lovely System a single-use or reusable device?

    The device data does not specify whether the Lovely System is single-use or reusable, but it is classified as a class 2 device with a product code of FTC.

  • What regulatory clearance does the Lovely System have?

    The Lovely System has FDA 510(k) clearance, with a 510(k) number of K033946, and is regulated under 21 CFR 878.4630.

  • What is the product code for the Lovely System?

    The product code for the Lovely System is FTC, and it is classified as a General, Plastic Surgery device.