Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) → OAP — Laser, Comb, Hair # OAP · Laser, Comb, Hair _Physical Medicine · 21 CFR 890.5500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP ## Overview - **Product Code:** OAP - **Device Name:** Laser, Comb, Hair - **Regulation:** [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K253669.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K253349.md) | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | Dec 24, 2025 | SESE | | [K252414](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K252414.md) | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Oct 30, 2025 | SESE | | [K252325](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K252325.md) | Hair Growth Laser Cap | Cosmo Far East Technology Limited | Oct 22, 2025 | SESE | | [K251017](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K251017.md) | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jun 17, 2025 | SESE | | [K250467](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K250467.md) | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | Jun 5, 2025 | SESE | | [K250308](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K250308.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K242747.md) | FAQ™ (302) | Foreo, Inc. | Dec 11, 2024 | SESE | | [K242619](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K242619.md) | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | Dec 2, 2024 | SESE | | [K242363](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K242363.md) | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Nov 20, 2024 | SESE | | [K241342](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K241342.md) | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | Nov 8, 2024 | SESE | | [K242620](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K242620.md) | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | Nov 1, 2024 | SESE | | [K240472](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K240472.md) | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | Oct 11, 2024 | SESE | | [K240689](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K240689.md) | Robin's Egg | Telebrands Corporation | Sep 17, 2024 | SESE | | [K242441](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K242441.md) | Revian Lyte (10011) | Revian, Inc. | Sep 13, 2024 | SESE | | [K240456](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K240456.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K240064.md) | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | Feb 7, 2024 | SESE | | [K232356](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K232356.md) | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | Oct 24, 2023 | SESE | | [K231321](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K231321.md) | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Jul 31, 2023 | SESE | | [K231153](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K231153.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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