510(k) Report

FDA applicant

Summit Technology, Inc.

Waltham, MA5 decisions1990–19981 recall

FDA records 5 decisions for Summit Technology, Inc. (Waltham, MA) from 1990 to 1998: 5 510(k) clearances. Most are in product codes EQH (Source, Carrier, Fiberoptic Light) and HQF (Laser, Ophthalmic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

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 Summit Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Summit Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Summit Technology, Inc.’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 “Summit”

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