The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Anti-wrinkle Light, Model 1302 And Pain Therapy Light, Model 1301.
Device ID | K083580 |
510k Number | K083580 |
Device Name: | ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 |
Classification | Lamp, Infrared, Therapeutic Heating |
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 | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-03 |
Decision Date | 2009-06-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850030819062 | K083580 | 000 |