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 Apr 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 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 29, 1982
Date Received
Mar 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
510(k) Exempt

Source: FDA 510(k) database entry for K820650. Report a data issue: hello@regdatalab.com.