Cleared Traditional

K052778 - THERMAGE THERMACOOL SKIN MARKETING

K052778 is an FDA 510(k) clearance for THERMAGE THERMACOOL SKIN MARKETING, 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 17-day FDA review.

K052778 · Thermage, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
17d
Days
Class 2
Risk

K052778 is an FDA 510(k) clearance for the THERMAGE THERMACOOL SKIN MARKETING. 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 October 20, 2005 after a review of 17 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.

View all Thermage, Inc. devices

FDA 510(k) Submission Details - K052778

510(k) Number K052778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date October 20, 2005
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 1350
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K052778.
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185
K052104 · Conmed Corporation · Oct 2005
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
K052857 · Senorx, Inc. · Oct 2005
AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
K052203 · Kirwan Surgical Products, Inc. · Oct 2005
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
K052449 · Codman & Shurtleff, Inc. · Oct 2005
STRYKER STILETTO ELECTROSURGICAL PROBE
K052141 · Stryker Endoscopy · Oct 2005
ARTHROCARE ARTHROWANDS
K052686 · Arthrocare Corp. · Oct 2005