510(k) Report

510(k) · Cleared

Cleared

Shields T.C. Laser Lens

K893731510(k) TraditionalCleared Aug 17, 198992-day reviewClass II21 CFR 886.4390

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

Ocular Instruments, Inc. · LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

Cleared on Aug 17, 1989 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 17, 1989
Review
92 days
Class
Class II
Product code
LQJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K893731Source: 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 LQJ? 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 LQJ devices

LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQJ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQJ

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

Recalls per year · LQJ

No recall names LQJ since 2007.

Adverse event reports per year · LQJ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code LQJ, 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—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Ocular Instruments, Inc.

50 FDA decisions under this applicant name. See the company

  • K014170Staurenghi Wide Field Scanning Laser LensOcular Instruments, Inc. · 2002
  • K012096Disposable Vitrectomy LensOcular Instruments, Inc. · 2001
  • K933976Mandelkorn Suture Lysis LensOcular Instruments, Inc. · 1994
  • K933264Ritch Nylon Suture Laser LensOcular Instruments, Inc. · 1994
  • K94142050 Degree Hri Prism LensOcular Instruments, Inc. · 1994

Recent decisions in LQJ

The LQJ category page

  • K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC · 2017
  • K931356Safe Air Vari-Spot Handpiece Telescope and AdaptorSorenson Laboratories, Inc. · 1993
  • K921414Trokel /3 Gonio Laser LensOcular Instruments, Inc. · 1992
  • K912112PF-400,GF-300,IF-200,PG400,PG400C,and ED-480Tomey Corporation USA · 1991
  • K884694MQL 20 ND:Yag Ophthalmic LaserCalifornia Laboratories, Inc. · 1988

https://510kreport.com/device/K893731 · printed Nov 4, 2026

Cite this page

510(k) Report. “K893731: Shields T.C. Laser Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893731

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