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IPL Hair Removal Device (UI06 PN +12 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233664

by Shenzhen Ulike Smart Electronics Co., Ltd.

Identifiers

510(k) Number
K233664 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
UI06 PN FDA 510(k)
UI06 PL FDA 510(k)
UI06 JL FDA 510(k)
UI06 BR FDA 510(k)
UI06 DB FDA 510(k)
UI06 PR FDA 510(k)
UI06 OG FDA 510(k)
UI06 RD FDA 510(k)
UI06 WH FDA 510(k)
UI06 MG FDA 510(k)
UI06 OB FDA 510(k)
UI06 LY FDA 510(k)
UI06 IG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Light-Based Over-the-Counter Hair Removal Device, classified under FDA product code OHT. It employs intense pulsed light (IPL) technology to target and reduce hair follicles, intended for non-invasive hair removal and long-term reduction of hair regrowth on the skin. The device is designed for consumer use without professional medical supervision, targeting areas such as the face, legs, arms, and other body regions. Its mechanism relies on controlled energy pulses to selectively damage hair follicles while minimizing damage to surrounding tissue.

The IPL Hair Removal Device is supplied as a single-use or reusable consumer device, depending on the model variant, and is intended for at-home use. It is not classified as sterile and is not intended for surgical or clinical settings. The device operates under FDA clearance as a Class II medical device under regulation 21 CFR 878.4810, with multiple registration numbers assigned for distribution. Storage instructions are not specified in the data, but typical IPL devices require proper handling to avoid damage to the light-emitting components. The device is authorized for over-the-counter (OTC) use by consumers for self-treatment.

Frequently asked questions

What skin areas can this IPL hair removal device safely target for at-home use?

This device is designed for non-invasive hair removal and long-term reduction of hair regrowth on various skin areas, including the face, legs, arms, and other body regions. It is intended for consumer use without professional medical supervision, but it is not meant for use on sensitive or damaged skin, nor is it approved for surgical or clinical settings.

Is this IPL device reusable or single-use, and how does that affect its maintenance?

The IPL Hair Removal Device comes in both single-use and reusable models, depending on the variant (e.g., UI06 PN, UI06 PL, etc.). Reusable models require proper handling to avoid damage to the light-emitting components, while single-use models do not require maintenance beyond initial setup. Always follow manufacturer guidelines to ensure safe and effective use.

How does the FDA classify this device, and what does that mean for its use?

This device is classified as a Class II medical device under FDA regulation 21 CFR 878.4810 and is authorized for over-the-counter (OTC) use. The classification means it has undergone a traditional 510(k) clearance process and is deemed substantially equivalent to a legally marketed predicate device, allowing consumers to use it at home for hair removal without professional supervision.

Are there specific storage instructions for this device, and what should I avoid to prolong its lifespan?

While the data does not specify exact storage instructions, typical IPL devices require protection from moisture, extreme temperatures, and physical damage to preserve the light-emitting components. Store the device in a clean, dry place away from direct sunlight or heat sources to ensure optimal performance and longevity.

How do I know which model variant (e.g., UI06 PN, UI06 PL) is right for my needs?

The model variants listed (e.g., UI06 PN, UI06 PL) likely correspond to different features, settings, or skin tone compatibility. Since the data does not detail specific differences, consult the manufacturer’s documentation or support for guidance on selecting the variant best suited for your skin type, hair color, and intended treatment areas. Always ensure the device is FDA-cleared for your region.

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: IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB ..., IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB ..., PDF Shenzhen Ulike Smart Electronics Co.,Ltd, ULIKE UI06 PR QUICK START MANUAL Pdf Download | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.

Sources (1)

  • FDA 510(k) K233664 24 fields · synced Oct 6, 2026