Cleared Traditional

K911288 - ORION

K911288 is the FDA 510(k) clearance for ORION by Pfizer Laser Systems. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 992-day FDA review.

K911288 · Pfizer Laser Systems · General & Plastic Surgery device
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Nov 1993
Decision
992d
Days
Class 2
Risk

K911288 is an FDA 510(k) clearance for the ORION. 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 Pfizer Laser Systems (Irvine, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 992 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Pfizer Laser Systems devices

Submission Details

510(k) Number K911288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1991
Decision Date November 16, 1993
Days to Decision 992 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
877d slower than avg
Panel avg: 115d · This submission: 992d
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 1171
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K911288.
ZEISS OPMILAS 144 SURGICAL LASERS
K932376 · Carl Zeiss, Inc. · Dec 1993
ZEISS VISULAS YAG II LASER
K926452 · Carl Zeiss, Inc. · Nov 1993
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · Boston Scientific Corp · Nov 1993
SHARPLAN SHARPLASE LATERAL ND:YAG FIBER
K930582 · Sharplan Lasers, Inc. · Nov 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K933322 · Carl Zeiss, Inc. · Oct 1993
VISIDISC KITS, SPINESCOPE
K924720 · Laserscope · Oct 1993