| K-number | K171398 |
| Device name | Dermal Cooling System |
| Applicant | R2 Dermatology ,Inc |
| Product code | GEH |
| Device class | Class II |
| Decision date | Jul 6, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 878.4350 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov