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Kiierr 272 Laser, Kiierr 148 Laser

by Kiierr International, LLC

510(k) K181878

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 NumberK181878 Date5 Sep 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  • Withdrawn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
OAP
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Kiierr 272 Laser and Kiierr 148 Laser are laser hair growth caps classified as a laser, comb, hair device. These helmet-style caps utilize low-level laser therapy via 148 or 272 laser diodes to stimulate hair follicles.

This device is intended for over-the-counter home use and is powered by a lithium-ion battery with an embedded controller. It is a Class II device under FDA 510(k) clearance K181878 and is regulated under product code OAP.

Questions

AI-generated answers, 21 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 primary function of the Kiierr laser caps?

    The Kiierr 272 and 148 Laser caps are designed to stimulate hair follicles. They achieve this by utilizing low-level laser therapy delivered through either 148 or 272 laser diodes integrated into the helmet-style device.

  • How is the device powered?

    The device is powered by a lithium-ion battery. It also features an embedded controller to manage the operation of the laser diodes during use.

  • Is this device intended for professional or home use?

    The Kiierr 272 and 148 Laser caps are intended for over-the-counter home use, allowing individuals to utilize the laser hair growth technology in a personal setting.

  • What is the regulatory status of these devices?

    These devices are classified as Class II medical devices under FDA 510(k) clearance number K181878. They are regulated under product code OAP, which pertains to laser, comb, and hair devices.