Cleared Traditional

K073158 - SCULPTURE 2.94 ER:YAG SYSTEM

K073158 is an FDA 510(k) clearance for SCULPTURE 2.94 ER:YAG SYSTEM, manufactured by Hoya Conbio, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K073158 · Hoya Conbio, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
293d
Days
Class 2
Risk

K073158 is an FDA 510(k) clearance for the SCULPTURE 2.94 ER:YAG SYSTEM. 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 Hoya Conbio, Inc. (Twain Harte, US). The FDA issued a Cleared decision on August 27, 2008 after a review of 293 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K073158

510(k) Number K073158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date August 27, 2008
Days to Decision 293 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
178d slower than avg
Panel avg: 115d · This submission: 293d
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 2836
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K073158.
PASCAL SYNTHESIS DELIVERY SYSTEM
K081744 · Optimedica Corporation · Sep 2008
STARLIGHT, MODEL PD9012
K073317 · F.P. Rubinstein Y Cia S.R.L. · Sep 2008
CLAROS NANO DENTAL LASER SYSTEM
K081652 · Elexxion AG · Aug 2008
MEDILAS D FAMILY LASERS
K073427 · Dornier Medtech America, Inc. · Aug 2008
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
K080530 · Cutera, Inc. · Aug 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939 · Omniguide, Inc. · Aug 2008
K073158 · SCULPTURE 2.94 ER:YAG SYSTEM
Download PDF FDA Summary Hoya Conbio, Inc.