510(k) Report

510(k) · Cleared

Cleared

Phoenix Laser Systems Ophthalmic Surgical Worksta.

K901605510(k) TraditionalCleared Dec 13, 1990252-day reviewClass II21 CFR 886.4392

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phoenix Laser Systems, Inc. · LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Cleared on Dec 13, 1990 after a 252-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 13, 1990
Review
252 days
Class
Class II
Product code
LXS
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K901605Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LXS devices

LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXS

FDA has decided no LXS device since 2007.

Median 510(k) review, days · LXS

Too few LXS 510(k)s in any year since 2007 to give a median.

Recalls per year · LXS

No recall names LXS since 2007.

Adverse event reports per year · LXS

2in 2021

2007: 32009: 12014: 32015: 182017: 32018: 62019: 42020: 12021: 2
2007high 18 (2015) · low 0 (2008)2025

MAUDE reports naming product code LXS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—03
20150—018
20160—00
20170—03
20180—06
20190—04
20200—01
20210—02
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in LXS

The LXS category page

  • K023045Microrupter VMeridian AG · 2002
  • K895864Microruptor Iii Syst, Q-Switched ND:Yag Laser CompLasag AG · 1989
  • K893987Nidek Model YC-1200Nidek, Inc. · 19891 recall
  • K892204Nidek Inc. Models YC-2000 & 3000 Ophthalmic LasersNidek, Inc. · 1989
  • K892058ISL QC 2000Intelligent Surgical Lasers, Inc. · 1989

https://510kreport.com/device/K901605 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901605: Phoenix Laser Systems Ophthalmic Surgical Worksta..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901605

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026