510(k) Report

510(k) · Cleared

Cleared

12.5MM Peyman Wide Field Yag Laser Lens

K872136510(k) TraditionalCleared Jun 19, 198716-day reviewClass II21 CFR 886.1385

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

Ocular Instruments, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

Cleared on Jun 19, 1987 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 19, 1987
Review
16 days
Class
Class II
Product code
HJK
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared1990200020102020
  1. This deviceK872136 12.5MM Peyman Wide Field Yag Laser LensOcular Instruments, Inc. · 1987
  2. Descendant · cites it directly · 0 of its ownK201909 RxSight Contact LensRxsight, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K201909RxSight Contact LensRxsight, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K87213612.5MM Peyman Wide Field Yag Laser LensOcular Instruments, Inc.1987—
+1K201909RxSight Contact LensRxsight, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K872136, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · 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 HJK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HJK device

  1. #1 K201909 RxSight Contact Lensscore -0.0 · 1 generation · no Class I recall
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201909RxSight Contact LensRxsight, Inc.20200

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.

What does this lineage say?

  • Of its descendants, K201909 (Rxsight, Inc., 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HJK devices

HJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HJK

1in 2020

2014: 12015: 12018: 12020: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HJK

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

Recalls per year · HJK

No recall names HJK since 2007.

Adverse event reports per year · HJK

1in 2025

2019: 32020: 22025: 1
2007high 3 (2019) · low 0 (2007)2025

MAUDE reports naming product code HJK, 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—00
20120—00
20130—00
20141—00
20151—00
20160—00
20170—00
20181—00
20190—03
20201—02
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
Cite this page

510(k) Report. “K872136: 12.5MM Peyman Wide Field Yag Laser Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872136

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