Cleared Traditional

K853900 - ENDO-LASE CD40 FOR NEUROSURGERY

K853900 is an FDA 510(k) clearance for ENDO-LASE CD40 FOR NEUROSURGERY, manufactured by Endo Lase, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K853900 · Endo Lase, Inc. · General & Plastic Surgery device
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Jun 1986
Decision
271d
Days
Class 2
Risk

K853900 is an FDA 510(k) clearance for the ENDO-LASE CD40 FOR NEUROSURGERY. 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 Endo Lase, Inc. (Washington, US). The FDA issued a Cleared decision on June 18, 1986 after a review of 271 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 Endo Lase, Inc. devices

FDA 510(k) Submission Details - K853900

510(k) Number K853900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1985
Decision Date June 18, 1986
Days to Decision 271 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
156d slower than avg
Panel avg: 115d · This submission: 271d
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 1801
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K853900.
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862423 · Directed Energy, Inc. · Sep 1986
COOPER LASER SONICS ND: YAG LASER, MODEL 8008
K853117 · Cooper Lasersonics, Inc. · Aug 1986
MODEL 545-45 LASER FOR DERMA., POD., SURGICAL
K860974 · Britt Corp., Inc. · Jul 1986
ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
K853878 · Endo Lase, Inc. · May 1986
SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
K854998 · Directed Energy, Inc. · May 1986
SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT
K855210 · Directed Energy, Inc. · May 1986