Cleared Traditional

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (K901605) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901605 · Phoenix Laser Systems, Inc. · Ophthalmic device
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Dec 1990
Decision
252d
Days
Class 2
Risk

K901605 is an FDA 510(k) clearance for the PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.. Classified as Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (product code LXS), Class II - Special Controls.

Submitted by Phoenix Laser Systems, Inc. (St.Petersburg, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 252 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4392 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Phoenix Laser Systems, Inc. devices

Submission Details

510(k) Number K901605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date December 13, 1990
Days to Decision 252 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 110d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXS Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4392
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 Ophthalmic devices follow this clearance model.