Fraxel Dual 1550/1927 Laser System

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

Fraxel DUAL EUDAMED

Fraxel GUDID

Fraxel re:store DUAL Laser System GUDID

Generic Name

Dermatological laser beam guiding handpiece

Device Name

Fraxel Tips

Fraxel DUAL 1550 Laser System

Fraxel DUAL 1550/1927 Refurbished

Model / Ref / Catalog

MC-F2-RT1L, MC-RS-CRTL-US, MC-SYS-SR1500-D-US, MC-SYS-SR1500-D-INTL, MC-SYS-SR1500-D-USR, MC-RS-CRTL-INTL

Primary DI / UDI-DI

00816995020004, 00816995020073, 00816995020233, 00816995027263, 00816995027010, 00816995027270

Basic UDI-DI

B-00816995027270, B-00816995020073, B-00816995027263, B-00816995020233, B-00816995020004, B-00816995027010

510(k) Number

K130193 ↗

FDA Product Code

GEX

EMDN Code

Z120615 Therapeutic lasers

GMDN Term

Dermatological laser beam guiding handpiece

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4810

EU market of registration

Netherlands

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

• Origins

  Class IIa

  CE/MDD

See all devices from Solta Medical, Inc. →

• What types of skin conditions can the Fraxel Dual 1550/1927 Laser System treat, and how does it work differently than other laser systems?

  The Fraxel Dual 1550/1927 Laser System is specifically designed for skin resurfacing and tissue remodeling, targeting conditions like wrinkles, scars, pigmentation, and photoaging. Unlike traditional ablative lasers that remove the top layer of skin, this device uses non-ablative fractional laser technology with dual wavelengths (1550 nm and 1927 nm) to deliver precise, controlled energy deep into the skin. This approach promotes collagen production and tissue regeneration while minimizing surface damage, making it suitable for sensitive or darker skin types.

• Is the Fraxel Dual 1550/1927 Laser System meant for in-office use only, and what training is required to operate it?

  Yes, the Fraxel Dual 1550/1927 Laser System is intended exclusively for clinical settings under physician supervision by qualified operators. Since it delivers laser energy, proper training in laser safety protocols and device operation is mandatory. The manufacturer, Solta Medical, likely provides training programs to ensure operators understand the system’s controls, safety measures, and treatment parameters before use.

• How is the Fraxel Dual 1550/1927 Laser System supplied, and is it single-use or reusable?

  The Fraxel Dual 1550/1927 Laser System is supplied as a reusable medical device, consisting of a console that houses the laser controls and dual fiber laser sources. Unlike disposable components, the console itself is designed for repeated use in clinical environments, though individual handpieces or consumables (e.g., handpieces, cooling devices) may require replacement or sterilization between patients to maintain safety and hygiene.

• What regulatory pathways does the Fraxel Dual 1550/1927 Laser System follow, and how does that affect its use?

  The Fraxel Dual 1550/1927 Laser System has been cleared by the FDA under a 510(k) submission (K130193) and complies with the Medical Device Directive (MDD) in Europe. This means it has undergone evaluation by regulatory bodies to demonstrate substantial equivalence to a predicate device (a previously approved laser system). Clinicians should confirm local compliance requirements, as regulatory status ensures the device meets safety and performance standards for its intended clinical use.