Frax 1940 for Nordlys and Frax Pro

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Frax 1940

Generic Name

Multi-modality skin surface treatment system generator

Model / Reference

9APP7908, Frax 1940 / 9APP7908

Primary DI / UDI-DI

00817495023489

Basic UDI-DI

B-00817495023489

510(k) Number

K212492 ↗

FDA Product Code

GEX

EMDN Code

Z12011019 Multi–platform laser

GMDN Term

Multi-modality skin surface treatment system generator

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4810

EU market of registration

Denmark

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Glace SBA103840

  Class I

  GUDID on market

• Glace SBA103878

  Class I

  GUDID on market

• Glace SBA103889

  Class I

  GUDID on market

• Glace FIN102956

  Class I

  GUDID on market

• Glace FIN102955

  Class I

  GUDID on market

• Glace SBA103900

  Class I

  GUDID on market

See all devices from Candela Corporation →

• What types of skin concerns is the Frax 1940 laser specifically designed to treat?

  The Frax 1940 is designed for skin resurfacing and rejuvenation, targeting pigmentation issues, fine lines, and mild scarring. It uses fractional non-ablative laser energy at 1940 nm to stimulate collagen remodeling while avoiding damage to the epidermis, making it suitable for improving skin texture and superficial imperfections.

• Is the Frax 1940 a single-use device or reusable, and what does that mean for my practice?

  The Frax 1940 is a reusable handpiece meant to be integrated with the Nordlys or Frax Pro laser systems. Since it’s not a single-use item, your practice must follow standard laser equipment protocols for maintenance and cleaning—no additional sterility measures are required beyond those already in place for your existing Candela systems.

• Which laser platforms can the Frax 1940 be used with, and how does that affect workflow?

  The Frax 1940 is compatible with both the Nordlys and Frax Pro laser platforms, allowing seamless integration into your current workflow. This means you can use it alongside your existing Candela systems without needing separate equipment, simplifying setup and reducing operational complexity for dermatological procedures.

• What regulatory pathway was followed for FDA clearance of the Frax 1940, and what does that mean for my practice?

  The Frax 1940 received FDA 510(k) clearance under the Traditional review pathway, specifically categorized under General, Plastic Surgery (product code GEX). This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets established safety and effectiveness standards for its intended use in dermatological treatments.