The following data is part of a premarket notification filed by Litecure, Llc with the FDA for Litecure Therapy System.
| Device ID | K103511 |
| 510k Number | K103511 |
| Device Name: | LITECURE THERAPY SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LITECURE, LLC 250 CORPORATE BLVD., SUITE B Newark, DE 19702 |
| Contact | Liang Lu |
| Correspondent | Liang Lu LITECURE, LLC 250 CORPORATE BLVD., SUITE B Newark, DE 19702 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854103007028 | K103511 | 000 |
| 00854103007011 | K103511 | 000 |