510(k) K091125

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 3, 2010

Date Received

April 17, 2009

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Powered Light Based Non-Laser Surgical Instrument

Device Class

Class II

Regulation Number

878.4810

Review Panel

SU

Submission Type

A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. 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, remove or coagulate tissue by the light.