510(k) K843063

ELECTRONIC EPILATOR TS-1 by R. A. Fischer Co. Corp. — Product Code KCW

K843063 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "ELECTRONIC EPILATOR TS-1". The FDA issued a decision of Substantially Equivalent on Sep 26, 1984. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. R. A. Fischer Co. Corp. has 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 26, 1984
Date Received
Aug 6, 1984
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
510(k) Exempt

Source: FDA 510(k) database entry for K843063. Report a data issue: hello@regdatalab.com.