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Fractional Skin Resurfacing Applicator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101510

by Endymed Medical Ltd

Identifiers

510(k) Number
K101510 FDA 510(k)
FDA Product Code
OUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fractional Skin Resurfacing Applicator is a radiofrequency (RF) device designed for fractional skin resurfacing. It delivers controlled thermal energy to the skin, creating microscopic treatment zones to stimulate collagen production, improve skin texture, and address conditions such as wrinkles, scars, and hyperpigmentation.

This device is intended for use in clinical settings by trained professionals and is classified as a Class II medical device under FDA regulations. It operates as a reusable applicator with multiple registered model numbers (e.g., 3008085016, 3018242561) and is authorized under FDA 510(k) clearance (K101510). The device is not single-use and requires proper sterilization between applications.

Frequently asked questions

What types of skin conditions can the Fractional Skin Resurfacing Applicator help treat, and how does it work?

The Fractional Skin Resurfacing Applicator delivers controlled radiofrequency (RF) energy to the skin, creating microscopic treatment zones that stimulate collagen production. This process helps improve skin texture, reduce wrinkles, and address conditions like scars and hyperpigmentation by promoting natural healing and remodeling of the skin.

Is the Fractional Skin Resurfacing Applicator single-use or reusable, and what sterilization methods are required?

The device is designed for reusable clinical use and must be properly sterilized between applications to ensure safety and prevent cross-contamination. Sterilization instructions should be followed as per manufacturer guidelines to maintain device integrity and compliance with regulatory standards.

How many model numbers are registered for this device, and what does this mean for purchasing or inventory management?

The device has multiple registered model numbers (e.g., 3008085016, 3018242561, and others listed in the data), indicating variations may exist for different clinical or procedural needs. When ordering, confirm the specific model number required for your facility’s intended use to ensure compatibility and proper inventory tracking.

What regulatory pathway was followed for FDA clearance of this device, and what does this imply for its clinical use?

The device received FDA clearance through a 510(k) submission (K101510) under the Traditional clearance type, with a determination of Substantially Equivalent to a predicate device. This means it was evaluated for safety and effectiveness by the FDA and is classified as a Class II medical device, intended for use in clinical settings by trained professionals in General, Plastic Surgery procedures.

What is the intended clinical setting for this device, and who should operate it?

The Fractional Skin Resurfacing Applicator is designed exclusively for clinical settings and should only be used by trained professionals with expertise in radiofrequency skin resurfacing. Its classification as a Class II device and registration under General, Plastic Surgery reflect its specialized use in controlled medical environments.

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: FSR Applicator - ENDYMED, Fractional Skin Resurfacing - Endymed, Fractional Skin Resurfacing FSR Applicator - Endymed Medical | FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Endymed Medical Ltd
FDA Applicant
Endymed Medical, Ltd.

Sources (1)

  • FDA 510(k) K101510 24 fields · synced Oct 6, 2026