Cleared Traditional

K950826 - AM RUBY

K950826 is an FDA 510(k) clearance for AM RUBY, manufactured by American Lasers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K950826 · American Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
279d
Days
Class 2
Risk

K950826 is an FDA 510(k) clearance for the AM RUBY. 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 American Lasers, Inc. (Alhambra, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 279 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.

View all American Lasers, Inc. devices

FDA 510(k) Submission Details - K950826

510(k) Number K950826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1995
Decision Date November 29, 1995
Days to Decision 279 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 115d · This submission: 279d
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 1884
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K950826.
CERALAS G FREQUENCY DOUBLED ND
K954834 · Ceram Optec, Inc. · Jan 1996
ECLIPSE 2100
K955006 · Cardiogenes · Jan 1996
ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
K951910 · Xintec Corporation · Dec 1995
OPTILITE VIII LASER SURGERY ACCESSORIES
K951760 · Xintec Corporation · Nov 1995
SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM
K952277 · Sharplan Lasers, Inc. · Nov 1995
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
K953794 · Sharplan Lasers, Inc. · Nov 1995