OAP — Laser, Comb, Hair Class II
Classification Details
- Product Code
- OAP
- Device Class
- Class II
- Regulation Number
- 890.5500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253669 | shenzhen kaiyan medical equipment co | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | January 23, 2026 |
| K253349 | light tree ventures europe | Hair Regrowth Cap (Model: T-119-HRC) | December 24, 2025 |
| K252414 | shenzhen kaiyan medical equipment co | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | October 30, 2025 |
| K252325 | cosmo far east technology limited | Hair Growth Laser Cap | October 22, 2025 |
| K251017 | shenzhen kaiyan medical equipment co | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | June 17, 2025 |
| K250467 | shenzhen idea light limited | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | June 5, 2025 |
| K250308 | dongguan boyuan intelligent technology co | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, K | April 29, 2025 |
| K242747 | foreo | FAQ (302) | December 11, 2024 |
| K242619 | apira science | GroWell BT Hair Growth System (GW10042) | December 2, 2024 |
| K242363 | shenzhen kaiyan medical equipment co | HIGHERDOSE Red Light Hat (HG-120K) | November 20, 2024 |
| K241342 | shenzhen nuon medical equipment co | Hair Growth Comb (SZ-23,SZ-23A) | November 8, 2024 |
| K242620 | shenzhen breo technology co | Breo Laser Hair Growth Comb (Scalp 3L) | November 1, 2024 |
| K240472 | dongguan tutamen metalwork co | PBM Hair Therapy Cap | October 11, 2024 |
| K240689 | telebrands corporation | Robin's Egg | September 17, 2024 |
| K242441 | revian | Revian Lyte (10011) | September 13, 2024 |
| K240456 | plm worldwide, llc d/b/a phoenix medical technology | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 L | May 22, 2024 |
| K240064 | wontech co | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | February 7, 2024 |
| K232356 | hubei yjt technology co | Laser Cap, Model: Hat-01 | October 24, 2023 |
| K231321 | shenzhen kaiyan medical equipment co | Nooance Led And Laser Helmet | July 31, 2023 |
| K231153 | nature, inc.redible | Neuhat Hair Growth System; ibeauty.com Laser Cap | June 23, 2023 |