Skip to content

Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

510(k) clearance

Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)

FDA 510(k) source

510(k) number
K262834
Applicant
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Decision date
Oct 9, 2026
Date received
Aug 11, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
OAP
Device type
Laser, Comb, Hair
Device class
Class II
Regulation
21 CFR 890.5500
Advisory committee
Physical Medicine
Statement or summary
Summary
Third party
N
Location
Shenzhen, CN