510(k) Report

FDA applicant

Sunrise Technologies, Inc.

Fremont, CA19 decisions1990–20000 recalls

FDA records 19 decisions for Sunrise Technologies, Inc. (Fremont, CA) from 1990 to 2000: 18 510(k) clearances and 1 original PMA approval. Most are in product codes GEX (Powered Laser Surgical Instrument) and KOJ (Airbrush). No 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, general and plastic surgery panel, where it files most

How often FDA has decided Sunrise Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunrise Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sunrise Technologies, 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 “Sunrise”

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