← Back to catalogue

Leaf Smooth

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212697

by Shenzhen Leaflife Technology Co., Ltd.

Identifiers

510(k) Number
K212697 FDA 510(k)
FDA Product Code
OHT 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)

The Leaf Smooth is a light-based, over-the-counter hair removal device. It is designed to facilitate the removal of unwanted hair using light-based technology.

This device is classified as a Class 2 medical device under regulation number 878.4810. It has received FDA 510(k) clearance.

Frequently asked questions

What is the Leaf Smooth used for?

The Leaf Smooth is a light-based hair removal device designed to remove unwanted hair through non-invasive technology. It is classified as an over-the-counter medical device, making it accessible for personal use at home without requiring a prescription.

How is the Leaf Smooth supplied?

The Leaf Smooth is supplied as a complete, ready-to-use device. It does not require additional components or accessories beyond what is included in the packaging. The device is intended for individual use and is not meant to be shared.

Is the Leaf Smooth sterile?

The Leaf Smooth is intended for single-use per the manufacturer’s specifications. While the device itself is not sterile upon initial packaging, it is designed to be used on clean, dry skin to minimize the risk of infection. Users should follow proper hygiene practices before and after use.

What models or variations of the Leaf Smooth are available?

The Leaf Smooth is available in multiple registration numbers, indicating different variants or configurations. These include registration numbers such as 3019015047, 3015989868, and others listed under the device’s regulatory details. These variations may differ in technical specifications or features, but all fall under the same core product category of light-based hair removal.

How should the Leaf Smooth be stored?

The Leaf Smooth should be stored in a clean, dry place, away from direct sunlight and extreme temperatures. Since it is intended for single-use or limited use, it should be kept in its original packaging until ready for use. Proper storage ensures the device remains effective and maintains its intended functionality.

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: Leaflife Technology: Manufacturers of Medical & Aesthetic Laser ..., Shenzhen Leaflife Technology Co., Limited, Shenzhen Leaflife Technology Co., Ltd. - Made-in-China.com, Shenzhen Leaflife Technology Co., Ltd Cheng Qiang 4 F,Bldg. C, JMD ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Leaflife Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K212697 24 fields · synced Oct 1, 2026