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)— 510(k) K262834
Substantially EquivalentShenzhen Jianchao Intelligent Technology Co., Ltd.
FDA 510(k) clearance K262834 for 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), Substantially Equivalent on 2026-10-09. Applicant: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Jianchao Intelligent Technology's LED and Laser Hair Growth Device is cleared across 17 model numbers, including H5520, H6520, and INIA-HM100. It's filed under OAP, the product code named "Laser, Comb, Hair." The record doesn't say which form factor each model takes.
Class II, 21 CFR 890.5500. The General and Plastic Surgery review panel handled it as a Traditional 510(k); the record lists Physical Medicine as the classification panel.
The company filed from Shenzhen, China, and the review took 59 days (August 11 to October 9, 2026). Its IPL hair removal device (K262352) cleared the same day after a 91-day review.
Clearance details
- Applicant
- Shenzhen Jianchao Intelligent Technology Co., Ltd.
- Product code
- Product code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OAP
view all- K262183 — Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- K262254 — Hair Growth Comb (X-GC01)
- K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
- K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
More clearances from Shenzhen Jianchao Intelligent Technology Co., Ltd.
view all- K262352 — IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)
- K261705 — Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
- K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K242710 — Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
Data sourced from openFDA. This site is unofficial and independent of the FDA.