The following data is part of a premarket notification filed by Weber Medical Gmbh with the FDA for Weberneedle Basic Laser.
| Device ID | K073352 |
| 510k Number | K073352 |
| Device Name: | WEBERNEEDLE BASIC LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | WEBER MEDICAL GMBH SOHNREYSTRASSE 6 Laurenforde, Niedersachsen, DE 37697 |
| Contact | Jurgen Hermann |
| Correspondent | Jeffrey Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-29 |
| Decision Date | 2008-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B45510551 | K073352 | 000 |