The following data is part of a premarket notification filed by Sonoscanner Sarl with the FDA for U-lite.
| Device ID | K143601 |
| 510k Number | K143601 |
| Device Name: | U-Lite |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Sonoscanner SARL 59 Rue De La Sante Paris, FR 75013 |
| Contact | Bruno Richard |
| Correspondent | Frank Ferguson Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, VA 23451 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-03-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() U-LITE 88650610 not registered Live/Pending |
Jiang Hong Mei 2019-10-11 |
![]() U-LITE 87558524 5504747 Live/Registered |
Ultra Bright Lightz 2017-08-07 |
![]() U-LITE 86757317 4945947 Live/Registered |
Sonoscanner SARL 2015-09-15 |
![]() U-LITE 75814765 2383169 Dead/Cancelled |
Scanlan, Daniel J. 1999-10-05 |
![]() U-LITE 75326528 not registered Dead/Abandoned |
John Manufacturing Ltd. (LLC) 1997-07-17 |
![]() U-LITE 73270409 1170081 Dead/Cancelled |
Interlectric Corporation 1980-07-16 |
![]() U-LITE 73141438 1089522 Dead/Cancelled |
Universal Shellac & Supply Co., Inc. 1977-09-16 |