Cleared Traditional

K051710 - THERMAGE THERMACOOL COUPLING FLUID

K051710 is an FDA 510(k) clearance for THERMAGE THERMACOOL COUPLING FLUID, manufactured by Thermage, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K051710 · Thermage, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
22d
Days
Class 2
Risk

K051710 is an FDA 510(k) clearance for the THERMAGE THERMACOOL COUPLING FLUID. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Thermage, Inc. (Hayward, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051710

510(k) Number K051710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date July 19, 2005
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2168
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K051710.
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
K051644 · Valleylab · Aug 2005
CLARIS NON-STICK BIPOLAR FORCEPS
K051429 · Guenter Bissinger Medizintechnik GmbH · Jul 2005
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT
K051627 · Valleylab · Jul 2005
BARRX HALO 360 SYSTEM, MODEL 1100C-115A
K051168 · Barrx Medical, Incorporated · Jun 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · Smith & Nephew, Inc. · May 2005
NON-STICK ELECTRODE
K043036 · Modern Medical Equipment Mfg., Ltd. · May 2005