FDA Approval Status

Glotech™ Hair Pro - FDA Details

Proprietary Name: LED Esthetics Hair Pro

Certifications / Regulatory Status: FDA-Cleared (Medical Device)

FDA Classification Name: Laser, Comb, Hair

FDA Product Code: OAP

FDA Regulation Number: 890.5500

FDA Registered Establishment Number: 3011644607

 

 

Technical Specs Overview:

Power Source: Built in rechargeable battery

No. of LEDs: 180 red LEDs

Treatment Modes:

• Hair restoration

LED Wavelengths:

• Red – 650nm

Irradiance: 5 mW/cm2

Treatment Time: 10 mins

Weight: 0.8 lbs

Material: Neoprene

 

 

 

Last Updated: 11/03/2025

Registration & Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=926840&lpcd=OAP