510(k) K222112
K222112 is an FDA 510(k) premarket notification submitted by Medical Precision BV for the device "Comfort Marker 2.0". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. The device falls under product code QRN (Radiation Therapy Marking Device), a Class II device regulated under 21 CFR 892.5785. Medical Precision BV has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2023
- Date Received
- Jul 18, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiation Therapy Marking Device
- Device Class
- Class II
- Regulation Number
- 892.5785
- Review Panel
- RA
- Submission Type
- 510(k)
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.