510(k) K820650
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