Product code OHT

Device name

Light Based Over-The-Counter Hair Removal

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4810

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

Source

FDA openFDA device classification dataset