The following data is part of a premarket notification filed by Clinical Laserthermia Systems Ab with the FDA for Tranberg Cls Thermal Therapy System.
| Device ID | K142216 |
| 510k Number | K142216 |
| Device Name: | Tranberg CLS Thermal Therapy System |
| 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 | 2014-08-12 |
| Decision Date | 2015-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17340007000543 | K142216 | 000 |
| 17340007000024 | K142216 | 000 |
| 17340007000017 | K142216 | 000 |
| 37340007000721 | K142216 | 000 |
| 37340007000714 | K142216 | 000 |
| 37340007000707 | K142216 | 000 |
| 37340007000691 | K142216 | 000 |
| 37340007000684 | K142216 | 000 |
| 37340007000677 | K142216 | 000 |
| 37340007000660 | K142216 | 000 |
| 37340007000653 | K142216 | 000 |
| 17340007000031 | K142216 | 000 |
| 17340007000048 | K142216 | 000 |
| 17340007000055 | K142216 | 000 |
| 17340007000390 | K142216 | 000 |
| 17340007000161 | K142216 | 000 |
| 17340007000154 | K142216 | 000 |
| 17340007000147 | K142216 | 000 |
| 17340007000130 | K142216 | 000 |
| 17340007000109 | K142216 | 000 |
| 17340007000093 | K142216 | 000 |
| 17340007000086 | K142216 | 000 |
| 17340007000079 | K142216 | 000 |
| 17340007000062 | K142216 | 000 |
| 17340007000611 | K142216 | 000 |