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SculpSure

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182741

by Cynosure

Identifiers

510(k) Number
K182741 FDA 510(k)
FDA Product Code
PKT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5400 FDA 510(k)
Regulation Number
878.5400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SculpSure is a Laser For Disruption Of Adipocyte Cells For Aesthetic Use, designed to selectively target and permanently eliminate fat cells through non-invasive lipolysis. This Class II device employs laser energy to reduce localized fat deposits in aesthetic areas, including the abdomen, flanks, thighs, and submental region, without surgical intervention or downtime.

Used in clinical settings by trained professionals, the SculpSure is a reusable device supplied as a system with multiple laser handpieces (FEI numbers 3026038437–3031944951). It is not sterile and requires proper handling per manufacturer instructions. The device holds FDA 510(k) clearance (K182741) under the General, Plastic Surgery advisory committee and is regulated under 21 CFR 878.5400. Storage and maintenance follow Cynosure’s guidelines to ensure operational integrity.

Frequently asked questions

What specific body areas can the SculpSure laser treat for fat reduction, and how does it work?

The SculpSure laser is designed to target and permanently eliminate fat cells in aesthetic areas such as the abdomen, flanks, thighs, and submental (chin) region. It achieves this through non-invasive laser energy, which selectively disrupts adipocyte cells (fat cells) without surgery or downtime, making it ideal for localized fat reduction.

Is the SculpSure device single-use or reusable, and what does that mean for my practice?

The SculpSure is a reusable device supplied as a system with multiple laser handpieces. Since it is not sterile, it must be handled and maintained according to Cynosure’s guidelines to ensure proper functionality and infection control between uses in clinical settings.

How many different handpieces does the SculpSure system include, and are they interchangeable?

The SculpSure system includes multiple laser handpieces, with FEI numbers ranging from 3026038437 to 3031944951. While the exact interchangeability isn’t specified, these handpieces are part of the same system and are designed for use with the SculpSure device, allowing flexibility for different treatment applications.

What regulatory pathway does the SculpSure follow, and which advisory committee was involved?

The SculpSure received FDA clearance through a traditional 510(k) process, classified as substantially equivalent under 21 CFR 878.5400. It was reviewed by the General, Plastic Surgery advisory committee (SU) and is regulated under product code PKT, reflecting its use in aesthetic fat reduction procedures.

Does the SculpSure require special storage conditions, and what should I consider when maintaining it?

While specific storage conditions aren’t detailed, Cynosure provides guidelines to ensure the SculpSure’s operational integrity. Proper maintenance, including cleaning and handling per manufacturer instructions, is critical to prevent damage or contamination, especially since the device is reusable and not sterile.

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: Body Contouring Machine | SculpSure® | Cynosure, Non-Invasive Body Contouring Treatment | Cynosure, SculpSure Side Effects, Results & How Long It Lasts - RealSelf

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cynosure

Sources (1)

  • FDA 510(k) K182741 24 fields · synced Sep 19, 2026