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iHelmet Hair Growth System

by Slinph Technologies Co., Ltd. 2 variants

510(k) K190467

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 NumberK190467 Date26 Dec 2019ClearedStatusActive

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  • Withdrawn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, 27 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 iHelmet Hair Growth System is a laser-based device intended to promote hair growth. It is indicated for use in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and in males with androgenetic alopecia who have Norwood-Hamilton Classifications IIa-V, for both Fitzpatrick Skin Phototypes I to IV.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K190467. It is classified as a Class II medical device under regulation number 890.5500 and product code OAP, with a medical specialty designation in Physical Medicine.

Other devices from Slinph Technologies Co., Ltd.

Questions

AI-generated answers, 27 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 iHelmet Hair Growth System used for?

    The iHelmet is a laser-based device intended to promote hair growth in females with Ludwig-Savin Classifications I-II and in males with Norwood-Hamilton Classifications IIa-V, for Fitzpatrick Skin Phototypes I to IV.

  • Is the iHelmet Hair Growth System reusable or single-use?

    The iHelmet Hair Growth System is supplied as a reusable system, designed for multiple applications rather than being disposable after a single use.

  • What regulatory approvals does the i Helmet Hair Growth System have?

    The device has received FDA 510(k) clearance under K190467 and is classified as a Class II medical device under regulation number 890.5500 with product code OAP in Physical Medicine.

  • How is the iHelmet Hair Growth System supplied?

    The iHelmet is supplied as a complete reusable system, though the specific components included in the package are not detailed in the available information.