ETHEREA


Device Classification Name

powered laser surgical instrument

510(k) Number K112505
Device Name ETHEREA
Applicant
REGULATORY INSIGHT, INC.
5401 s.cottonwood court
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
REGULATORY INSIGHT, INC.
5401 s.cottonwood court
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ILY   ONF  
Date Received 08/30/2011
Decision Date 04/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No