The following data is part of a premarket notification filed by Clinical Laserthermia Systems, Ab with the FDA for Tranberg Cls Laser Applicator.
| Device ID | K201466 |
| 510k Number | K201466 |
| Device Name: | Tranberg CLS Laser Applicator |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Clinical Laserthermia Systems, AB Scheelevägen 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 | 2020-06-02 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37340007000608 | K201466 | 000 |
| 37340007000592 | K201466 | 000 |
| 37340007000585 | K201466 | 000 |
| 37340007000578 | K201466 | 000 |
| 37340007000561 | K201466 | 000 |
| 37340007000783 | K201466 | 000 |
| 37340007000776 | K201466 | 000 |
| 37340007000769 | K201466 | 000 |
| 17340007000734 | K201466 | 000 |