← Product Code [OAP](/productcode/OAP) · K262183

# Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) (K262183)

_Shenzhen Nuon Medical Equipment Co., Ltd. · OAP · Sep 24, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262183

## Device Facts

- **Applicant:** Shenzhen Nuon Medical Equipment Co., Ltd.
- **Product Code:** [OAP](/productcode/OAP.md)
- **Decision Date:** Sep 24, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5500
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

## 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.

---

**Source:** [https://fda.innolitics.com/device/K262183](https://fda.innolitics.com/device/K262183)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com