Nanolas ND:Yag Ophthalmic Laser

K881459510(k) TraditionalCleared Apr 13, 19887-day reviewClass III

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

Biophysic Medical, Inc. · LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Cleared on Apr 13, 1988 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Apr 13, 1988
Review: 7 days
Class: Class III
Product code: LOI
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K881459Source: FDA 510(k) database · How lineage is built

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.

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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 LOI devices

LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOI

FDA has decided no LOI device since 2007.

Median 510(k) review, days · LOI

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

Recalls per year · LOI

No recall names LOI since 2007.

Adverse event reports per year · LOI

No MAUDE report names LOI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K881459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881459: Nanolas ND:Yag Ophthalmic Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881459

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Record history

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