The following data is part of a premarket notification filed by Clinical Laserthermia Systems Ab with the FDA for Tranberg Cls Laser Fiber.
| Device ID | K151569 |
| 510k Number | K151569 |
| Device Name: | Tranberg CLS Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Clinical Laserthermia Systems AB Scheelevagen 2 Lund, SE 22381 |
| Contact | Lars Erik Eriksson |
| Correspondent | David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, OK 73013 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17340007000505 | K151569 | 000 |
| 57340007000497 | K151569 | 000 |
| 17340007000178 | K151569 | 000 |