The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Anti-wrinkle (aging) Light, Model Aal.
Device ID | K092800 |
510k Number | K092800 |
Device Name: | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL |
Classification | Powered Light Based Non-laser Surgical Instrument |
Applicant | LED INTELLECTUAL PROPERTIES, LLC 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
Contact | Robert T Wagner |
Correspondent | Robert T Wagner LED INTELLECTUAL PROPERTIES, LLC 1131 ANTHEM VIEW LANE Knoxville, TN 37922 |
Product Code | ONE |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-11 |
Decision Date | 2010-02-04 |
Summary: | summary |