FDA 510(k)

iHelmet Laser Comb

K-Number: K202631 · 2020-12-08

Decision Date2020-12-08

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

iHelmet Laser Comb is a medical device manufactured by Slinph Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-12-08 under approval number K202631. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iHelmet Laser Comb?

iHelmet Laser Comb is a medical device that received FDA 510(k) clearance on 2020-12-08. It is manufactured by Slinph Technologies Co., Ltd.. The 510(k) number is K202631.

When was iHelmet Laser Comb approved by the FDA?

iHelmet Laser Comb received FDA 510(k) clearance on 2020-12-08, under approval number K202631.

What company makes iHelmet Laser Comb?

iHelmet Laser Comb is manufactured by Slinph Technologies Co., Ltd..

What is the FDA product code for iHelmet Laser Comb?

The FDA product code for iHelmet Laser Comb is OAP.

Other Devices by Slinph Technologies Co., Ltd.

K162782iHelmet Hair Growth System K190467iHelmet Hair Growth System

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K152587DermaScalp Laser CapDermascalp, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.