Cleared Traditional

K041721 - LVI AESTHETIC LASER

K041721 is an FDA 510(k) clearance for LVI AESTHETIC LASER, manufactured by Hoya Photonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K041721 · Hoya Photonics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
42d
Days
Class 2
Risk

K041721 is an FDA 510(k) clearance for the LVI AESTHETIC LASER. 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 Photonics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 5, 2004 after a review of 42 days - a notably fast clearance 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: 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 - K041721

510(k) Number K041721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2004
Decision Date August 05, 2004
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 2800
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K041721.
FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
K041829 · Focus Medical, LLC · Sep 2004
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
K041419 · Medical Energy, Inc. · Aug 2004
DURALITE-GL
K041262 · Laser Scientific · Aug 2004
VERSAWAVE DENTAL ER:YAG LASER SYSTEM
K041710 · Hoya Conbio · Aug 2004
ACNELIFT
K041103 · Inner Act, LLC · Jul 2004
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K030290 · Millennium Dental Technologies, Inc. · Jul 2004
K041721 · LVI AESTHETIC LASER
Download PDF FDA Summary Hoya Photonics, Inc.