Cleared Traditional

ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER (K896517) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896517 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
86d
Days
Class 2
Risk

K896517 is an FDA 510(k) clearance for the ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER. 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 Heraeus Lasersonics, Inc. (Milpitas, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 86 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.

View all Heraeus Lasersonics, Inc. devices

Submission Details

510(k) Number K896517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date February 09, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 2864
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K896517.
LumiGlam Laser System (SHE-LSP601-3)
K260690 · Beijing Sano Laser S&T Development Co.,Ltd · Jun 2026
LASEmaR 1500
K260489 · Eufoton S.R.L. · May 2026
LUNE PureHygiene
K260138 · Enamel Pure · May 2026
Boston 2910 (Boston 2910)
K253245 · Boston Aesthetics, Inc. · May 2026
MOSES Raydar™
K260100 · Boston Scientific Corporation · May 2026
PICO SHINING (PICO-K
K261214 · Speclipse, Inc. · May 2026