FDA.reportPublic FDA data

General cryosurgical system, thermo-electric cooler

Definition
An assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen).
GUDID devices
9
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850019947564Dermal Cooling SystemR2 Technologies, Inc.M1-TIP1-102023-06-09
00850019947861Dermal Cooling SystemR2 Technologies, Inc.M1-TIP1-202023-06-09
00850019947991Dermal Cooling SystemR2 DERMATOLOGY INC.M1-TIP1-202023-06-09
00850019947045Dermal Cooling SystemR2 Technologies, Inc.HP-0022022-02-01
00850019947533Dermal Cooling SystemR2 Technologies, Inc.M1-SC-FR2-100-02022-02-01
00850019947007Dermal Cooling SystemR2 Technologies, Inc.C2-0012021-03-31
00850019947014Dermal Cooling SystemR2 Technologies, Inc.HP-0052021-03-31
00850019947182Dermal Cooling SystemR2 Technologies, Inc.M1-SC-FR1-100-12021-03-31
B563HP0040Dermal Cooling SystemR2 Technologies, Inc.HP-0042019-08-20