Cleared Traditional

K083461 - IMAGINE TC SKIN THERAPY SYSTEM

K083461 is an FDA 510(k) clearance for IMAGINE TC SKIN THERAPY SYSTEM, manufactured by Endymion Medical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K083461 · Endymion Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
245d
Days
Class 2
Risk

K083461 is an FDA 510(k) clearance for the IMAGINE TC SKIN THERAPY SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Endymion Medical, Ltd. (Binyamina, IL). The FDA issued a Cleared decision on July 24, 2009 after a review of 245 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Endymion Medical, Ltd. devices

FDA 510(k) Submission Details - K083461

510(k) Number K083461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date July 24, 2009
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 115d · This submission: 245d
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 1377
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K083461.
SPINEWAND SURGICAL DEVICE
K091228 · Arthrocare Corp. · Sep 2009
ERBE HYBRID KNIFE
K083608 · Erbe USA, Inc. · Aug 2009
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
K080844 · Gyrus Acmi, Inc. · Aug 2009
CODMAN ISOCOOL BIPOLAR FORCEPS
K083895 · Codman & Shurtleff, Inc. · Jun 2009
ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144
K090393 · Arthrocare Corp. · Jun 2009
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
K083281 · Linvatec Corp. · Feb 2009