FDA 510(k) clearance · back to tracker

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)

Shenzhen Jianchao Intelligent Technology Co., Ltd. cleared K262834 on 2026-10-09, decision: substantially equivalent

K-number

K262834

Sponsor

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Device

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)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-09

Product code

OAP

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.5500

Official FDA record

Open K262834on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.