Cheveux Diode Laser System
by Sandstone Medical Technologies, LLC
510(k) K100893
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100893 | Date16 Jun 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Cheveux Diode Laser System is a diode laser system substantially equivalent to other existing diode laser systems in commercial distribution for use in dermatology and plastic surgery. It is used for permanent hair reduction. The system operates at a wavelength of 810nm. The Cheveux Diode Laser System is designed to provide safe and effective treatments.
The Cheveux Diode Laser System is supplied with a smooth flow technology that allows for 10 pulses per second. It is authorized with an FDA 510(k) clearance, specifically K100893. The system is intended for use in a clinical setting, and its specifications and clearances are outlined in the FDA 510(k) summary.
Other devices from Sandstone Medical Technologies, LLC
Questions
AI-generated answers, 24 Sep 2026
What is the Cheveux Diode Laser System used for?
The Cheveux Diode Laser System is used for permanent hair reduction in dermatology and plastic surgery.
What wavelength does the Cheveux Diode Laser System operate at?
The Cheveux Diode Laser System operates at a wavelength of 810nm.
How many pulses per second can the Cheveux Diode Laser System deliver?
The Cheveux Diode Laser System can deliver 10 pulses per second with its smooth flow technology.