510(k) Report

FDA applicant

Lightmed Corp.

Shulin City, TW10 decisions2001–20161 recall

FDA records 10 decisions for Lightmed Corp. (Shulin City, TW) from 2001 to 2016: 10 510(k) clearances. All are in product code HQF (Laser, Ophthalmic). Its devices cite 17 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Lightmed Corporation”.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Lightmed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12009: 32011: 12013: 12015: 12016: 1
2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lightmed Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lightmed Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Lightmed”

FDA records each applicant name separately; these may or may not be the same firm.