FDA Approval Status
Glotech™ Minis - FDA Details
Proprietary Name: LED Esthetics Glotech Minis
Certifications / Regulatory Status: FDA-Cleared (Medical Device)
FDA Classification Name: Light Based Over The Counter Wrinkle Reduction
FDA Product Code: OHS
FDA Regulation Number: 878.4810
FDA Registered Establishment Number: 3011644607
Technical Specs Overview:
Power Source: 9 Tri-core LEDs – 27 bulbs
No. of LEDs: 9 LED bulbs
Treatment Modes:
- Anti-aging
- Color correction
LED Wavelengths:
- Red – 630nm
- Near Infrared – 830nm
- Yellow – 590nm
Irradiance: 35 mW/cm2
Treatment Time: 9 mins
Weight: 3.6oz
Material: Medical-Grade Silicone
Last Updated: 11/03/2025
Registration Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=889451lpcd=OHS