510(k) K820650

LPS 1118 by L.P. Systems Corp. — Product Code KCW

K820650 is an FDA 510(k) premarket notification submitted by L.P. Systems Corp. for the device "LPS 1118". The FDA issued a decision of Substantially Equivalent on April 29, 1982. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. L.P. Systems Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
March 9, 1982
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