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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Epilator, High Frequency, Needle-Type
510(k) Number K945192
Device Name HAIR REMOVAL SYSTEM
Applicant
L.P. Systems Corp.
87-14 116th St.
Richmond Hill,  NY  11418
Applicant Contact LUCY PETERS
Correspondent
L.P. Systems Corp.
87-14 116th St.
Richmond Hill,  NY  11418
Correspondent Contact LUCY PETERS
Regulation Number878.5350
Classification Product Code
KCW  
Date Received10/24/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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