The following data is part of a premarket notification filed by Clinical Laserthermia Systems Ab with the FDA for Tranberg Cls Diffusor Laser Fiber.
| Device ID | K163103 |
| 510k Number | K163103 |
| Device Name: | Tranberg CLS Diffusor 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17340007000529 | K163103 | 000 |
| 57340007000466 | K163103 | 000 |
| 57340007000459 | K163103 | 000 |
| 37340007000288 | K163103 | 000 |
| 37340007000271 | K163103 | 000 |