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Cynosure Phototripter Laser

FDA 510(k)

Class II (US FDA 510(k))

510(k) K921840

by Cynosure, Inc.

Identifiers

510(k) Number
K921840 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 Phototriptor Laser is a medical device classified as a laser for dermatological use, designed for non-invasive skin treatments. It emits targeted laser energy to address vascular lesions, pigmentation disorders, and hair removal by selectively absorbing chromophores in the skin. This device operates within the visible and near-infrared spectrum to achieve therapeutic effects without penetrating deeply into surrounding tissues. Its application is rooted in dermatological and cosmetic procedures, where precision and controlled energy delivery are critical.

The Phototriptor Laser is supplied as a reusable medical device, intended for use in clinical settings such as dermatology clinics, plastic surgery offices, and medical spas. It requires proper training and adherence to manufacturer guidelines for safe operation, including maintenance of sterility for handpieces and accessories. The device is FDA-cleared under the 510(k) pathway (K921840) and falls under the General, Plastic Surgery advisory committee classification. No specific MRI safety classification is stated, and its use must comply with local regulatory and safety standards.

Frequently asked questions

What types of skin treatments is the Phototriptor Laser specifically designed to address, and how does it work?

The Phototriptor Laser is designed for non-invasive dermatological treatments targeting vascular lesions, pigmentation disorders, and hair removal. It achieves this by emitting controlled laser energy in the visible and near-infrared spectrum, which selectively targets specific chromophores (like hemoglobin or melanin) in the skin without deeply penetrating surrounding tissues. This precision allows for targeted treatment of these conditions while minimizing damage to adjacent healthy tissue.

Is the Phototriptor Laser a single-use device, or is it meant for repeated use in clinical settings?

The Phototriptor Laser is a reusable medical device intended for use in clinical settings like dermatology clinics or plastic surgery offices. While the main unit itself is reusable, proper sterility protocols must be followed for handpieces and accessories to ensure safe and hygienic operation, as outlined in the manufacturer’s guidelines.

What kind of training or expertise is required to operate the Phototriptor Laser safely?

The Phototriptor Laser requires proper training and adherence to manufacturer guidelines for safe operation. Since it is used for dermatological and cosmetic procedures, clinicians must understand its precise energy delivery mechanisms and follow safety protocols to avoid unintended tissue damage or adverse effects.

How is the Phototriptor Laser regulated, and what does its FDA clearance status mean for users?

The Phototriptor Laser is FDA-cleared under the 510(k) pathway (K921840), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device meets FDA safety and effectiveness requirements for its intended dermatological uses, but users must still follow local regulations and manufacturer instructions for proper operation.

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: Cynosure Lutronic - Enhance your practice. Expand your services., Medical Lasers | Aesthetic Laser Devices | Cynosure Lutronic, Cynosure Laser | Medical Aesthetic Laser Technology - Precision ..., CYNOSURE PHOTOTRIPTER LASER (K921840) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cynosure, Inc.

Sources (1)

  • FDA 510(k) K921840 24 fields · synced Sep 20, 2026