510(k) K240314

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 21, 2024

Date Received

February 2, 2024

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Device Class

Class II

Regulation Number

878.4810

Review Panel

SU

Submission Type

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.