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Slinph Technologies Co., Ltd.

3 FDA records filed under this company name, from 2017 to 2020, in hair growth (OAP, 3).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 3)

510(k) clearedDec 8, 2020

iHelmet Laser Comb

510(k) number: K202631
Applicant: Slinph Technologies Co., Ltd.
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 11, 2020

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedDec 26, 2019

iHelmet Hair Growth System

510(k) number: K190467
Applicant: Slinph Technologies Co., Ltd.
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 26, 2019

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedApr 4, 2017

iHelmet Hair Growth System

510(k) number: K162782
Applicant: Slinph Technologies Co., Ltd.
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Oct 3, 2016

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)