K222112 is an FDA 510(k) clearance for the Comfort Marker 2.0. This device is classified as a Radiation Therapy Marking Device (Class II - Special Controls, product code QRN).
Submitted by Medical Precision BV (Zwolle, NL). The FDA issued a Cleared decision on March 30, 2023, 255 days after receiving the submission on July 18, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5785. A Radiation Therapy Marking Device Is A Powered Device That Transdermally Delivers A Permanent Or Temporary Colorant To The Skin For The Purpose Of Placing Marks To Guide Radiation Therapy. This Classification Does Not Include Devices With Reusable Or Reprocessed Needles Or Devices Intended For Diagnostic, Therapeutic, Or Aesthetic Use Or To Deliver Other Products For These Uses..
| 510(k) Number | K222112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | March 30, 2023 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QRN - Radiation Therapy Marking Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5785 |
| Definition | A Radiation Therapy Marking Device Is A Powered Device That Transdermally Delivers A Permanent Or Temporary Colorant To The Skin For The Purpose Of Placing Marks To Guide Radiation Therapy. This Classification Does Not Include Devices With Reusable Or Reprocessed Needles Or Devices Intended For Diagnostic, Therapeutic, Or Aesthetic Use Or To Deliver Other Products For These Uses. |