Cleared Traditional

K901605 - PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.

K901605 is an FDA 510(k) clearance for PHOENIX LASER SYSTEMS OPHTHALMIC SURGIC..., manufactured by Phoenix Laser Systems, Inc.. The device is a Class 2 Ophthalmic device with product code LXS cleared through the Traditional 510(k) pathway after a 252-day FDA review.

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

FDA 510(k) Submission Details - K901605

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.

LXS Device Classification - Class 2, Special Controls

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.