Shaser HRS2 RX Hair Removal System

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

510(k) Number

K132266 ↗

FDA Product Code

ONF

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Shaser Skin Beauty Intense Pulsed Light System Family for Acne

  Class II

  FDA 510(k) K150282 Active Cleared 27 May 2015

• Shaser V-Mini RX

  Class II

  FDA 510(k) K132170 Active Cleared 26 Nov 2013

• Lumena Fh Hair Removal System

  Class II

  FDA 510(k) K140631 Active Cleared 16 May 2014

• Shaser V-Mini Hair Removal System

  Class II

  FDA 510(k) K130015 Active Cleared 13 Jun 2013

• Shaser Skin Beauty Intense Pulsed Light System Family

  Class II

  FDA 510(k) K141583 Active Cleared 22 Jul 2014

• Shaser Ipl Hair Removal System

  Class II

  FDA 510(k) K103560 Active Cleared 18 May 2011

See all devices from Shaser, Inc. →

• How is the Shaser HRS2 RX Hair Removal System intended to be used in clinical practice, and who is the target user group?

  The Shaser HRS2 RX Hair Removal System is designed for clinical dermatological use to reduce unwanted hair growth through selective photothermal technology, targeting hair follicles while minimizing damage to surrounding tissue. It is intended for trained professionals such as dermatologists or plastic surgeons, as indicated by its advisory committee classification under General and Plastic Surgery. The system is not intended for home use or non-medical settings.

• Is the Shaser HRS2 RX Hair Removal System reusable, and if so, what sterilization methods are required?

  Yes, the Shaser HRS2 RX is supplied as a reusable medical device, meaning it must be properly sterilized between uses to ensure patient safety. While the data does not specify exact sterilization methods, standard practices for reusable surgical instruments—such as autoclaving or chemical sterilization—are typically required. Always follow manufacturer guidelines and facility protocols for sterilization.

• What regulatory pathway was used for FDA clearance of the Shaser HRS2 RX Hair Removal System, and what does this mean for compliance?

  The Shaser HRS2 RX received FDA clearance through the Traditional 510(k) pathway, specifically under clearance number K132266. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA safety and performance standards. The system is classified as a Class 2 device under regulation 878.4810, indicating it carries moderate risk and requires adherence to FDA-mandated controls.

• Are there any specific storage requirements or considerations for the Shaser HRS2 RX Hair Removal System?

  The provided data does not explicitly detail storage requirements for the Shaser HRS2 RX. However, as a reusable medical device, it should be stored in a clean, dry, and protected environment to prevent contamination or damage. If the device has disposable components (not mentioned in the data), those should follow their own storage guidelines. Always refer to the manufacturer’s instructions for complete storage protocols.