The following data is part of a premarket notification filed by Led Intellectual Properties Llc with the FDA for Lightstim Professional Led Bed.
| Device ID | K153399 |
| 510k Number | K153399 |
| Device Name: | LightStim Professional LED Bed |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LED Intellectual Properties LLC 16552 Von Karman Ave Irvine, CA 92606 |
| Contact | Steve Marchese |
| Correspondent | Steve Marchese LED Intellectual Properties LLC 16552 Von Karman Ave Irvine, CA 92606 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2016-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030819017 | K153399 | 000 |