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SideLaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121127

by Cynosure, Inc.

Identifiers

510(k) Number
K121127 FDA 510(k)
FDA Product Code
GEX 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 SideLaze Laser Beam Delivery Accessory is a side-firing fiber optic accessory designed for Cynosure 1440nm wavelength surgical lasers. It directs laser energy laterally to the fiber axis, enabling precise soft tissue procedures such as incision, excision, vaporization, ablation, coagulation, and laser-assisted lipolysis.

This accessory is supplied as a reusable component for use with compatible Cynosure laser systems and is classified under the GEX product code (Powered Laser Surgical Instrument). It is intended for use in surgical settings and has received FDA 510(k) clearance under Special Controls for Class II devices. No additional sterility or MRI safety information is specified.

Frequently asked questions

What types of surgical procedures can the SideLaze accessory be used for with a Cynosure 1440nm laser?

The SideLaze accessory directs laser energy laterally from the fiber axis, making it suitable for precise soft tissue procedures such as incision, excision, vaporization, ablation, coagulation, and laser-assisted lipolysis. Its design enables controlled energy delivery for these specific applications when paired with compatible Cynosure 1440nm wavelength lasers.

Is the SideLaze accessory single-use or reusable, and how should it be handled between uses?

The SideLaze accessory is explicitly designed as a reusable component for use with Cynosure laser systems. Since it is not sterile out-of-the-box and no sterility specifications are provided, proper cleaning, maintenance, and sterilization protocols (as outlined by the manufacturer) must be followed between uses to ensure safety and performance in surgical settings.

How is the SideLaze accessory regulated, and what does that mean for its use in clinical settings?

The SideLaze accessory has received FDA 510(k) clearance under Special Controls for Class II devices, with a product code of GEX (Powered Laser Surgical Instrument). This classification means it is subject to FDA oversight to ensure safety and effectiveness for its intended use with Cynosure 1440nm lasers in surgical procedures. Clinicians should confirm compatibility with their specific laser system and follow manufacturer guidelines for proper operation.

What advisory committee was involved in the regulatory review of this device, and why does that matter?

The SideLaze accessory was reviewed by the General, Plastic Surgery (SU) Advisory Committee during its FDA 510(k) clearance process. This committee provides expert input on devices intended for soft tissue procedures, including those relevant to plastic surgery. Their involvement helps ensure the device meets standards for safety and efficacy in procedures like laser-assisted lipolysis or coagulation, which are within their area of specialization.

What should I consider when storing the SideLaze accessory to maintain its performance?

While specific storage instructions aren’t detailed in the data, reusable laser accessories like the SideLaze typically require protection from physical damage, contamination, and environmental factors (e.g., moisture or extreme temperatures). The manufacturer’s guidelines should be consulted for proper storage conditions, especially if the accessory is cleaned or sterilized between uses. Ensuring it remains clean and undamaged will help preserve its precision and functionality for lateral laser energy delivery.

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: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength ..., SIDELAZE LASER BEAM DELIVERY ACCESSORY ... (K121127) - FDA 510(k), Sidelaze800 Laser Beam Delivery Accessory for Cynosure 1440mm ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cynosure, Inc.

Sources (1)

  • FDA 510(k) K121127 24 fields · synced Sep 19, 2026