New Regulations Target Red Light Therapy Devices Amid Retinal Damage Findings
PILLAR DIAGNOSTIC // WEEK 06
“The coherent laser-based RLT devices carry a high ocular safety risk: their beams exceed ANSI/JAMA limits in under three seconds and have been linked to clinical retinal damage, supporting a Class III reclassification and warranting strict safeguards against eye exposure.”
Proposed action
Enforce prominent ocular‐exposure warnings in labeling and instructions, prohibit any intended retinal application, and commission targeted safety studies on retinal irradiance thresholds to refine use guidelines.
THE MECHANICS
Spread & delivery
—
THE MACHINE
Evidence & systems
Two evaluated devices deliver coherent laser beams that surpass ANSI safety limits for short viewing durations.
THE MAP
Policy & population
Red light therapy instruments in China were reclassified due to clinical reports of retinal damage following treatment.
THE MOOD
Trust & behavior
—