Higherdose Red Light Hat (HG-120K)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242363 FDA 510(k)
- FDA Product Code
- OAP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Higherdose Red Light Hat (HG-120K) is a wearable phototherapy device designed for low-level laser therapy. It delivers targeted red light (650nm ± 10nm) via 120 integrated LEDs to the scalp, intended for androgenetic alopecia treatment.
The device is supplied as a reusable, non-sterile Class II medical device (Product Code: OAP) under 21 CFR 890.5500. It includes a rechargeable lithium battery, controller, and treatment program for 10-minute sessions. The device received FDA 510(k) clearance as substantially equivalent under the Traditional pathway, with regulatory filing K242363.
Frequently asked questions
What is the primary use case for the Higherdose Red Light Hat (HG-120K) and how does it work?
The Higherdose Red Light Hat (HG-120K) is designed for low-level laser therapy to target androgenetic alopecia (male/female pattern hair loss). It delivers red light (650nm ± 10nm) via 120 integrated LEDs to the scalp during 10-minute treatment sessions. The device uses a rechargeable lithium battery and built-in controller to administer the phototherapy, aiming to stimulate hair growth by promoting cellular activity in hair follicles.
Is the Higherdose Red Light Hat reusable or single-use, and what does that mean for maintenance?
The device is reusable, meaning it is intended for repeated use by multiple patients (not a single-patient-use item). Since it is non-sterile, proper cleaning and disinfection between uses are required to maintain hygiene. The manufacturer’s instructions should specify how to safely sanitize the device to prevent cross-contamination.
How is the device powered, and how long does a typical treatment session last?
The Higherdose Red Light Hat (HG-120K) includes a rechargeable lithium battery for power. Each treatment session is designed to last 10 minutes, during which the integrated LEDs deliver the red light therapy. The battery capacity should support multiple sessions before requiring recharging, though exact runtime depends on usage patterns.
What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians?
The device received FDA 510(k) clearance under the Traditional pathway, determined to be substantially equivalent (SESE) to a legally marketed predicate. This means the FDA reviewed it against an existing, cleared device (in this case, likely another low-level laser therapy product) and found it to meet safety and effectiveness standards for its intended use. Clinicians can rely on this clearance as evidence of regulatory scrutiny for its safety and performance.
Are there different sizes or models available for the Higherdose Red Light Hat, and how do I choose the right one?
The provided data does not specify multiple sizes or models for the HG-120K—it is described as a single device variant. However, the 120 integrated LEDs suggest it is designed to cover a standard scalp area for adult use. If fitting issues arise (e.g., for pediatric or larger adult scalps), the manufacturer’s instructions should be consulted for adjustments or alternative recommendations, though no additional models are listed in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Shenzhen Kaiyan Medical Equipment Co., Ltd, HIGHERDOSE Red Light Hat (HG-120K) (K242363) - Innolitics, K242363 FDA 510 (k) - HIGHERDOSE Red Light Hat (HG-120K)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242363 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
- FDA Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K242363 24 fields · synced Sep 19, 2026