Dermal Cooling System— 510(k) K213294

Substantially Equivalent

R2 Technologies, Inc.

FDA 510(k) clearance K213294 for Dermal Cooling System, Substantially Equivalent on 2022-11-10. Applicant: R2 Technologies, Inc.. Device class: 2.

Clearance details

Applicant: R2 Technologies, Inc.
Product code: Code QPZ
Device class: Class 2
Regulation: 21 CFR 878.4340
Advisory panel: General, Plastic Surgery
Date received: 2021-10-01
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPZ

K203006 — R2 Dermabrasion Tip (for Dermal Cooling System)2021-08-05

More clearances from R2 Technologies, Inc.

K201260 — Dermal Cooling System2020-09-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.