The following data is part of a premarket notification filed by Laser Lipo Limited with the FDA for Strawberry, Strawberry & Cream.
Device ID | K130341 |
510k Number | K130341 |
Device Name: | STRAWBERRY, STRAWBERRY & CREAM |
Classification | Fat Reducing Low Level Laser |
Applicant | LASER LIPO LIMITED HEATH HOUSE, CROCKHAM HILL Edenbridge, Kent, GB Tn8 6st |
Contact | Ian Cobley |
Correspondent | Ian Cobley LASER LIPO LIMITED HEATH HOUSE, CROCKHAM HILL Edenbridge, Kent, GB Tn8 6st |
Product Code | OLI |
CFR Regulation Number | 878.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-02-11 |
Decision Date | 2013-09-06 |
Summary: | summary |