FDA.reportPublic FDA data

510(k) K945192

Device
Hair Removal System
Applicant
L.P. SYSTEMS CORP.
510(k) number
K945192
Product code
KCW
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-12
Date received
1994-10-24
Regulation
878.5350
Classification name
Epilator, High Frequency, Needle-Type
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LUCY PETERS
Address
87-14 116th St. Richmond Hill NY US 11418 11418

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.1996-01-05
K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.1995-10-18
K943928APILUS ELECTROPILDectro Intl., Inc.1995-01-12
K943399THE SS-99Instantron1994-09-16
K943398THE BLENDTONE ROYALEInstantron1994-09-16
K943396THE ELITE SPECTRUMInstantron1994-09-16
K941227SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVALInstantron1994-08-18
K931062THE VP500 EPILATORInstantron1993-07-08
K931063THE ELITE EPILATORInstantron1993-07-08
K931064THE BLENDTONE EPILATORInstantron1993-07-08
K911983WIZARD STERILIZED ELECTROEPILATION NEEDLESkin Deep, Inc.1991-10-15
K904015ELECTRO-BLEND EPILATOR, MODEL UC-3A.R. Hinkel Co., Inc.1990-10-04
K895687D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)Carol Block, Ltd.1990-08-09
K894771EPILATION NEEDLEPrecision Electrolysis Needles, Inc.1989-08-21
K893389MODEL SE-5 EPILATORR. A. Fischer Co. Corp.1989-06-05