510(k) K895687

D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) by Carol Block, Ltd. — Product Code KCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
September 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epilator, High Frequency, Needle-Type
Device Class
Class I
Regulation Number
878.5350
Review Panel
SU
Submission Type