The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Lightstim Anti-wrinkle Otc Model Aal Otc.
Device ID | K101190 |
510k Number | K101190 |
Device Name: | LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | LED INTELLECTUAL PROPERTIES, LLC 9832 CHESTERFIELD CIRCLE Santa Ana, CA 92705 |
Contact | Robert T Wagner |
Correspondent | Robert T Wagner LED INTELLECTUAL PROPERTIES, LLC 9832 CHESTERFIELD CIRCLE Santa Ana, CA 92705 |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-28 |
Decision Date | 2010-07-01 |
Summary: | summary |