510(k) K242363
- Device
- HIGHERDOSE Red Light Hat (HG-120K)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- 510(k) number
- K242363
- Product code
- OAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-20
- Date received
- 2024-08-09
- Regulation
- 890.5500
- Classification name
- Laser, Comb, Hair
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alain Dijkstra
- Address
- Bldg.#3 And Bldg.#5, 40th Of Fuxin St. Huaide Community Fuyong Town, Baoan District Shenzhen CN 518103 518103
FDA Registration Numbers#
- 3043140693
- 3043729119
- 3030265332
- 3038373471
- 3013503862
- 3014737458
- 3020900954
- 3008855505
- 3006546131
- 3021349626
- 3009118729
- 3043149902
- 3009765778
- 3023876581
- 3012327767
- 3015249767
- 3033847811
- 3043012240
- 3030234143
- 3013519365
- 3008295459
- 3016245372
- 3018949797
- 3010162782
- 3014467408
- 3015060197
- 3042228064
- 3006182775
- 3012104022
- 3011644607
- 3016076077
- 3019015047
- 3015086789
- 3015191560
- 3016661372
- 3013472744
- 3010321647
- 3010027944
- 3010724743
- 3017905264
- 3006206425
- 3025432379
- 3006368133
- 3013553501
- 3015313684
- 3012541016
- 3015287734
- 3006985208
- 3010309303
- 3012234230
- 3012512142
- 3023339107
- 3018317166
- 3036498001
- 3008393409
- 3014755446
- 3010123655
- 3015415349
- 3013387006
- 3030220360
- 3017422691
- 3043012074
- 3043011436
- 2248223
- 3011258423
Source Documents#
Other 510(k) Records For Product Code OAP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-23 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | 2025-12-24 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-30 |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | 2025-10-22 |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-17 |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | 2025-06-05 |
| K250308 | 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) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-04-29 |
| K242747 | FAQ™ (302) | Foreo, Inc. | 2024-12-11 |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | 2024-12-02 |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-11-08 |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | 2024-11-01 |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | 2024-10-11 |
| K240689 | Robin's Egg | Telebrands Corporation | 2024-09-17 |
| K242441 | Revian Lyte (10011) | Revian, Inc. | 2024-09-13 |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | 2024-05-22 |