Cleared Traditional

K043255 - ELLIPSE LIGHT SPT

K043255 is an FDA 510(k) clearance for ELLIPSE LIGHT SPT, manufactured by Danish Dermatologic Development A/S. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K043255 · Danish Dermatologic Development A/S · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
92d
Days
Class 2
Risk

K043255 is an FDA 510(k) clearance for the ELLIPSE LIGHT SPT. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Danish Dermatologic Development A/S (Horsholm, DK). The FDA issued a Cleared decision on February 24, 2005 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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 Danish Dermatologic Development A/S devices

FDA 510(k) Submission Details - K043255

510(k) Number K043255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date February 24, 2005
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 1989
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K043255.
VAPORMAX
K050412 · Trimedyne, Inc. · Mar 2005
RELIANT LASER II SYSTEM AND ACCESSORIES
K042319 · Reliant Technologies, Inc. · Mar 2005
AURORA SR AND SRA APPLICATOR
K050452 · Syneron Medical, Ltd. · Mar 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · Candela Corp. · Feb 2005
COOLTOUCH, MODEL CT3S
K043046 · New Star Lasers, Inc. · Feb 2005
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
K043173 · Lumenis, Ltd. · Jan 2005