← Back to catalogue

Cynosure Photolight PL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031258

by Cynosure, Inc.

Identifiers

510(k) Number
K031258 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 Cynosure Photolight PL is a pulsed light device (GEX product code) designed for non-invasive photomedical treatments. It delivers controlled pulses of broad-spectrum light to target vascular lesions, benign pigmented lesions, and hair follicles for permanent hair reduction or photocoagulation. The system operates via a flashlamp-based light source, enabling precise energy delivery for therapeutic effects on skin and hair.

This device is supplied as a reusable medical system with application-specific handpieces for versatility. It includes a CoolHand cooling device to minimize epidermal thermal injury and patient discomfort during treatment. The Photolight PL is FDA-cleared under 510(k) K031258 as substantially equivalent to a predicate device, intended for use in clinical settings by trained professionals. No sterility or single-use designation is specified in the regulatory submission.

Frequently asked questions

What is the Cynosure Photolight PL used for?

The Photolight PL is designed for non-invasive photomedical treatments targeting vascular lesions (such as spider veins), benign pigmented lesions, and hair follicles. It delivers controlled pulses of broad-spectrum light to achieve permanent hair reduction or photocoagulation of targeted skin issues. The device’s flashlamp-based technology allows precise energy delivery, making it suitable for clinical settings where trained professionals administer treatments.

Is the Photolight PL a single-use or reusable device?

The Cynosure Photolight PL is supplied as a reusable medical system. It includes application-specific handpieces for versatility and a CoolHand cooling device to minimize patient discomfort during treatment. Reusability is supported by its design for clinical use, where proper maintenance and sterilization protocols must be followed between procedures.

Does the Photolight PL come with any additional features for patient comfort?

Yes, the Photolight PL includes a CoolHand cooling device, which helps reduce epidermal thermal injury and discomfort during treatment. This feature is particularly useful for patients undergoing procedures that involve light-based energy delivery, as it helps maintain skin integrity and improves the overall treatment experience.

What regulatory approval does the Photolight PL hold?

The Cynosure Photolight PL is FDA-cleared under 510(k) clearance number K031258, determined to be substantially equivalent to a predicate device. This clearance allows its use in clinical settings for the specified indications, provided it is operated by trained professionals following established protocols.

How many handpieces does the Photolight PL include, and what are they used for?

The Photolight PL system is supplied with application-specific handpieces, which provide versatility for different treatment needs. While the exact number or specific types of handpieces are not detailed in the regulatory data, these handpieces are designed to optimize energy delivery for vascular lesions, pigmented lesions, and hair reduction procedures. The inclusion of multiple handpieces allows clinicians to select the appropriate tool based on the patient’s condition and treatment goals.

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: PhotoLight™ Pulsed Light System from Cynosure, Inc, CYNOSURE PHOTOLIGHT PL (K031258) — FDA 510 (k) | Innolitics, K974674 FDA 510(k) - CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM

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
Cynosure, Inc.

Sources (1)

  • FDA 510(k) K031258 24 fields · synced Oct 1, 2026