510(k) K163103 ยท GEX Powered Laser Surgical Instrument
Tranberg CLS Diffusor Laser Fiber
| Applicant | Clinical Laserthermia Systems, AB, Lund, SE |
| Decision | Substantially Equivalent, Mar 23, 2017 |
| Received | Nov 7, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2021 | CLINICAL LASERTHERMIA SYSTEMS AB Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.