OAP — Laser, Comb, Hair Class II
FDA product code OAP covers "Laser, Comb, Hair", a Class II medical device regulated under 21 CFR 890.5500. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261675 | shenzhen chuanghong zhilian technology co | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D | July 17, 2026 |
| K261253 | ziree co | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H | June 26, 2026 |
| K260899 | zdeer technology (henan) co | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157 | June 16, 2026 |
| K253231 | hubei yjt technology co | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Las | June 16, 2026 |
| K251684 | alma lasers | Alma TED+ System | June 5, 2026 |
| 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 |