Cleared Traditional

K903849 - MODEL RD-1200 RUBY LASER SYSTEM

K903849 is an FDA 510(k) clearance for MODEL RD-1200 RUBY LASER SYSTEM, manufactured by Charles L. Rose and Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K903849 · Charles L. Rose and Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
15d
Days
Class 2
Risk

K903849 is an FDA 510(k) clearance for the MODEL RD-1200 RUBY LASER 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 Charles L. Rose and Co., Inc. (Mountain View, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 15 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 Charles L. Rose and Co., Inc. devices

FDA 510(k) Submission Details - K903849

510(k) Number K903849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date September 05, 1990
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 2355
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K903849.
COHERENT DIODE PHOTOCOAGULATOR
K903689 · Lumenis, Inc. · Sep 1990
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
K900890 · Nidek, Inc. · Sep 1990
NIDEK, INC. MODEL ADC-8000 DERM
K900925 · Nidek, Inc. · Sep 1990
LASER-SHIELD II(TM)
K901016 · Xomed, Inc. · Aug 1990
COHERENT XA30/SP AND XA50 SURGICAL LASERS
K902470 · Lumenis, Inc. · Jul 1990
SLT CONTACT LASER SYSTEMS (UROLOGY)
K902241 · Surgical Laser Technologies, Inc. · Jul 1990