The following data is part of a premarket notification filed by Lightmed Usa, Inc. with the FDA for Lightsonic Bubm.
| Device ID | K170761 |
| 510k Number | K170761 |
| Device Name: | LIGHTSonic BUBM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Lightmed USA, Inc. 1130 Calle Cordillera San Clemente, CA 92673 |
| Contact | Katrina Hsu |
| Correspondent | Angel Hsieh Lightmed USA, Inc. 1130 Calle Cordillera San Clemente, CA 92673 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2018-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853386006285 | K170761 | 000 |