OAP · Laser, Comb, Hair · Chrysalis Intelligence

Device class

Class II

Regulation 890.5500

Total clearances

2020-01-29 → 2026-09-24

Last 12 months

Unique sponsors

Definition

What is Laser, Comb, Hair

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

Classification details

Medical specialty

Physical Medicine

Review panel

Regulation number

890.5500

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Shenzhen Kaiyan Medical Equipment Co., Ltd.	5	2	2026-01-23
Hubei Yjt Technology Co.,Ltd	3	1	2026-06-16
Light Tree Ventures Europe B.V.	3	1	2025-12-24
Shenzhen Nuon Medical Equipment Co., Ltd.	2	1	2026-09-24
Wontech Co., Ltd.	2	0	2024-02-07
Nature, Inc.redible, Inc.	2	0	2023-06-23
Freedom Laser Therapy, Inc.	2	0	2022-10-13
Kam Yuen Plastic Products , Ltd.	2	0	2022-05-26
Telebrands Corporation	1	0	2024-09-17
Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC	1	0	2024-05-22
Dongguan Boyuan Intelligent Technology Co.,Ltd	1	0	2025-04-29
Foreo, Inc.	1	0	2024-12-11
Transdermal Cap, Inc.	1	0	2021-03-29
Dongguan Tutamen Metalwork Co., Ltd.	1	0	2024-10-11
Conversion Labs, Pr, LLC	1	0	2020-03-25
Advihair S.R.L.	1	0	2020-12-03
Y & J Bio Co., Ltd.	1	0	2020-12-08
Leana Orders, Inc.	1	0	2021-07-20
Xuzhou Kernel Medical Equipment Co., Ltd.	1	0	2020-06-03
Alma Lasers, Inc.	1	1	2026-06-05
Revian, Inc.	1	0	2024-09-13
Apira Science, Inc.	1	0	2024-12-02
Yibin Yingtong Intelligent Technology Co., Ltd.	1	0	2022-06-24
Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC	1	0	2020-01-29
Xtrallux, LLC	1	0	2022-11-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
97166	CPT	—	Medium	Physical medicine treatment with low-level laser or light therapy
97167	CPT	—	Medium	Therapeutic procedure code for phototherapy in hair growth application

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-24	K262183	Shenzhen Nuon Medical Equipment Co., Ltd.	Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
2026-09-23	K262254	Guangdong Ashmore Health Technology Co., Ltd.	Hair Growth Comb (X-GC01)
2026-07-17	K261675	Shenzhen Chuanghong Zhilian Technology Co., Ltd.	CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
2026-06-26	K261253	Ziree Co., Ltd.	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)
2026-06-16	K260899	Zdeer Technology (Henan) Co., Ltd.	Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
2026-06-16	K253231	Hubei Yjt Technology Co.,Ltd	Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
2026-06-05	K251684	Alma Lasers, Inc.	Alma TED+ System
2026-01-23	K253669	Shenzhen Kaiyan Medical Equipment Co., Ltd.	TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
2025-12-24	K253349	Light Tree Ventures Europe B.V.	Hair Regrowth Cap (Model: T-119-HRC)
2025-10-30	K252414	Shenzhen Kaiyan Medical Equipment Co., Ltd.	Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
2025-10-22	K252325	Cosmo Far East Technology Limited	Hair Growth Laser Cap
2025-06-17	K251017	Shenzhen Kaiyan Medical Equipment Co., Ltd.	CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
2025-06-05	K250467	Shenzhen Idea Light Limited	Red Light Hair Growth Cap (LP-RJVGRW-BLK)
2025-04-29	K250308	Dongguan Boyuan Intelligent Technology Co.,Ltd	Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
2024-12-11	K242747	Foreo, Inc.	FAQ (302)
2024-12-02	K242619	Apira Science, Inc.	GroWell BT Hair Growth System (GW10042)
2024-11-20	K242363	Shenzhen Kaiyan Medical Equipment Co., Ltd.	HIGHERDOSE Red Light Hat (HG-120K)
2024-11-08	K241342	Shenzhen Nuon Medical Equipment Co., Ltd.	Hair Growth Comb (SZ-23,SZ-23A)
2024-11-01	K242620	Shenzhen Breo Technology Co., Ltd.	Breo Laser Hair Growth Comb (Scalp 3L)
2024-10-11	K240472	Dongguan Tutamen Metalwork Co., Ltd.	PBM Hair Therapy Cap
2024-09-17	K240689	Telebrands Corporation	Robin's Egg
2024-09-13	K242441	Revian, Inc.	Revian Lyte (10011)
2024-05-22	K240456	Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC	Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
2024-02-07	K240064	Wontech Co., Ltd.	Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
2023-10-24	K232356	Hubei Yjt Technology Co.,Ltd	Laser Cap, Model: Hat-01