FDA.reportPublic FDA data

510(k) K970338

Device
TWEEZER-TYPE EPILATOR
Applicant
Igia Direct, Inc.
510(k) number
K970338
Product code
KCX
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-01
Date received
1997-01-29
Regulation
878.5360
Classification name
Epilator, High Frequency, Tweezer-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
JAMES R MARSHALL, PH.D.
Address
7 - Old Colony Dr. Westford MA US 01886 01886

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973773DAPELLE HAIR REMOVERWellquest Intl., Inc.1997-12-17
K973340TWEEZER-TYPE EPILATORMobit, Inc.1997-12-03
K973179FEMINIQUE SONIC HAIR REMOVERGlobal TV Concepts, Ltd.1997-10-30
K973174SONIQUE HAIR REMOVERGlobal TV Concepts, Ltd.1997-10-30
K972695FINALLY FREEMehl/Group Marketing1997-10-22
K935706EPI 2Universal H.R. System, Inc.1997-02-11
K943872COMMANDER MARK II HAIR REMOVAL SYSTEMThe Helene Edgar Corp.1995-10-26
K952117EPILATORBurke Neutech, Inc.1995-10-19
K915845HAIR TRONICS MODEL HT8000Global Tronics Intl., Inc.1992-07-29
K905125GUARANTY HAIR REMOVAL SYSTEMStephens Mfg. Co.1991-08-05
K892514AHRS EPILATOR 629American Hair Removal System Co.1990-08-14
K851413EPILATOR 8500Lois Yee Cosmetics, Inc.1985-06-10
K843735SOFTEPILNemectron Medical, Inc.1984-10-25
K843734NEMDINemectron Medical, Inc.1984-10-25
K770791DEPILATOR, DERMA-I & DERMA-IIElectro-Kinetic Eng/Mfg1981-01-26