Reliant Laser II System and Accessories

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

510(k) Number

K042319 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Fralex Sr 1500 Laser System (Fralex II Sr Laser System)

  Class II

  FDA 510(k) K070284 Active Cleared 17 May 2007

• Fraxel III Sr Laser System and Accessories

  Class II

  FDA 510(k) K063038 Active Cleared 27 Apr 2007

• Unimax Model 2500 Multiwavelength Color Corrected

  Class II

  FDA 510(k) K943045 Active Cleared 13 Dec 1994

• Fraxel SR Laser System

  Class II

  FDA 510(k) K050841 Active Cleared 5 Jul 2005

• Reliant Laser System II

  Class II

  FDA 510(k) K040617 Active Cleared 15 Jun 2004

• Accuscan Model C CO2 Laser Scanner

  Class II

  FDA 510(k) K953670 Active Cleared 26 Jan 1996

See all devices from Reliant Technologies, Inc. →

• What is the Reliant Laser II System and Accessories intended for?

  The Reliant Laser II System and Accessories is intended for use in general and plastic surgery settings, as indicated in its FDA 510(k) clearance documentation, making it suitable for procedures requiring laser-based tissue interaction in those clinical environments.

• How is the Reliant Laser II System and Accessories supplied and is it reusable?

  The device is supplied as a system with accessories, but the provided data does not specify whether components are single-use or reusable; therefore, reusability cannot be determined from the available information and should be confirmed via the manufacturer’s labeling or instructions for use.

• What regulatory pathway was used for the Reliant Laser II System and Accessories?

  The Reliant Laser II System and Accessories received FDA 510(k) clearance through the traditional pathway, as stated in the device data, meaning it was found substantially equivalent to a legally marketed predicate device following a 196-day review process.