510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203006Substantially Equivalent

R2 Dermabrasion Tip (for Dermal Cooling System)

R2 Technologies, Inc., San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203006 is the FDA 510(k) clearance record for R2 Dermabrasion Tip (for Dermal Cooling System), a class II device, cleared for R2 Technologies, Inc. on under FDA product code QPZ (Contact Cooling For Skin Lesion Pain Relief). FDA's definition for product code QPZ reads: "For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures". FDA records list 3 510(k) clearances for R2 Technologies, Inc., from to . As of , FDA records show no recalls naming K203006.

Clearance record

Decision date
Received
(308 days to decision)
Product code
QPZ Contact Cooling For Skin Lesion Pain Relief
Regulation
21 CFR 878.4340
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
R2 Technologies, Inc. 2603 Camino Ramon, Suite 200, San Ramon CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPZ

Trailing 12 months

FDA records hold no clearances under product code QPZ in the trailing twelve months.

FDA records show no clearances under product code QPZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260