FDA product code OAP: Laser, Comb, Hair
OAP is the FDA product code for laser, comb, hair. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 112 510(k) submissions under OAP, 38 in the last five years, from 59 different applicants. The average 510(k) review took 121 days (median 90); 117 days on average over the last three years. FDA has posted 1 recall for OAP devices, 1 initiated in the last five years.
Definition
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Classification
| Field | Value |
|---|---|
| Device name | Laser, Comb, Hair |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for OAP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 123 |
| 2018 | 15 | 95 |
| 2019 | 9 | 114 |
| 2020 | 9 | 139 |
| 2021 | 5 | 87 |
| 2022 | 8 | 138 |
| 2023 | 8 | 107 |
| 2024 | 10 | 110 |
| 2025 | 6 | 89 |
| 2026 | 6 | 152 |
Compare with all 510(k) review times · Search every OAP clearance
Top OAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lexington International, LLC | 8 | 2018-06-20 |
| Capillus, LLC | 7 | 2017-01-31 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 5 | 2026-01-23 |
| Theradome, Inc. | 5 | 2018-05-18 |
| Apira Science, Inc. | 4 | 2024-12-02 |
54 more applicants have OAP clearances. See the full list in Caduvo.
Most recent OAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| 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) | 2026-07-17 | 57 |
| 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) | 2026-06-26 | 71 |
| K260899 | Zdeer Technology (Henan) Co., Ltd. | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | 2026-06-16 | 90 |
| 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) | 2026-06-16 | 260 |
| K251684 | Alma Lasers, Inc. | Alma TED+ System | 2026-06-05 | 368 |
Recalls for OAP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-01.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OAP?
OAP is the FDA product code for laser, comb, hair. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the General and Plastic Surgery panel.
What device class is OAP?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAP?
Across 112 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most OAP clearances?
Lexington International, LLC (8); Capillus, LLC (7); Shenzhen Kaiyan Medical Equipment Co., Ltd. (5); Theradome, Inc. (5); Apira Science, Inc. (4).
Have OAP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-09-01.
Next steps
- Run an FDA pathway report with predicate devices for product code OAP
- Run a recall and safety report across every OAP manufacturer
- Watch product code OAP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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