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Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

by Home Well Trading, Ltd.

510(k) K181121

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 NumberK181121 Date28 Jun 2018ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 1 Oct 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 Light Based Over-The-Counter Hair Removal system, classified as a Class II medical device under regulation number 878.4810. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway under K-number K181121.

It is intended for over-the-counter use in the removal of unwanted body and/or facial hair in adults. The device is supplied as a non-sterile, reusable system for home use, with no indication of MRI safety or specific storage requirements provided in the data.

Other devices from Home Well Trading, Ltd.

Questions

AI-generated answers, 1 Oct 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 Beurer IPL 5500 device used for?

    The Beurer IPL 5500 device is intended for over-the-counter use in the removal of unwanted body and/or facial hair in adults, as a light-based hair removal system designed for home use.

  • Is the Beurer IPL 5500 device sterile or non-sterile, and is it reusable?

    The device is supplied as a non-sterile, reusable system for home use, meaning it is not sterilized before use and can be used multiple times by the same individual following manufacturer instructions.

  • What regulatory pathway was used to clear the Beurer IPL 5500 device?

    The Beurer IPL 5500 device was cleared via the traditional 510(k) pathway under K-number K181121, demonstrating substantial equivalence to a predicate device under regulation number 878.4810.