OAP · Laser, Comb, Hair
Physical Medicine · 21 CFR 890.5500 · Class 2
Overview
| Product Code | OAP |
|---|---|
| Device Name | Laser, Comb, Hair |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
Classification Rationale
Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 107)
Showing 20 most recent of 107 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jan 23, 2026 | SESE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | Dec 24, 2025 | SESE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Oct 30, 2025 | SESE |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | Oct 22, 2025 | SESE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jun 17, 2025 | SESE |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | Jun 5, 2025 | SESE |
| 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 | Apr 29, 2025 | SESE |
| K242747 | FAQ (302) | Foreo, Inc. | Dec 11, 2024 | SESE |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | Dec 2, 2024 | SESE |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Nov 20, 2024 | SESE |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | Nov 8, 2024 | SESE |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | Nov 1, 2024 | SESE |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | Oct 11, 2024 | SESE |
| K240689 | Robin's Egg | Telebrands Corporation | Sep 17, 2024 | SESE |
| K242441 | Revian Lyte (10011) | Revian, Inc. | Sep 13, 2024 | SESE |
| 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 | May 22, 2024 | SESE |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | Feb 7, 2024 | SESE |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | Oct 24, 2023 | SESE |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jul 31, 2023 | SESE |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | Jun 23, 2023 | SESE |
Top Applicants
- Lexington International, LLC — 8 clearances
- Capillus, LLC — 7 clearances
- Shenzhen Kaiyan Medical Equipment Co., Ltd. — 5 clearances
- Theradome, Inc. — 5 clearances
- Apira Science, Inc. — 4 clearances
