FDA Approval Status
Glotech™ Mask Pro - FDA Details
Proprietary Name: LED Esthetics Silicone Mask
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: External rechargeable battery (wireless)
No. of LEDs: 198 LED bulbs
Treatment Modes:
- Anti-aging
- Anti-acne
LED Wavelengths:
- Red – 630nm
- Near Infrared – 830nm
- Blue – 415nm
Irradiance: 44 mw/cm2, 30 mw/cm2
Treatment Time: 10 mins
Weight: 0.8 lbs
Material: Medical-Grade Silicone
Last Updated: 11/03/2025
Registration & Device Listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=816181&lpcd=OHS