Cleared Traditional

K854998 - SURGICAL CO2 LASER SYSTEM #20/OPTICAL F...

K854998 is an FDA 510(k) clearance for SURGICAL CO2 LASER SYSTEM #20/OPTICAL F..., manufactured by Directed Energy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K854998 · Directed Energy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
141d
Days
Class 2
Risk

K854998 is an FDA 510(k) clearance for the SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC. 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 Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 141 days - within the typical 510(k) review window.

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 Directed Energy, Inc. devices

FDA 510(k) Submission Details - K854998

510(k) Number K854998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date May 02, 1986
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
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 1536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K854998.
COOPER LASER SONICS ND: YAG LASER, MODEL 8008
K853117 · Cooper Lasersonics, Inc. · Aug 1986
ENDO-LASE CD40 FOR NEUROSURGERY
K853900 · Endo Lase, Inc. · Jun 1986
ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
K853878 · Endo Lase, Inc. · May 1986
SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT
K855210 · Directed Energy, Inc. · May 1986
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · Sharplan Lasers, Inc. · Apr 1986
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
K854386 · Directed Energy, Inc. · Mar 1986