510(k) Report

FDA applicant

Telstar Innovations, Inc.

Bensalem, PA1 decision1994–19940 recalls

FDA records 1 decision for Telstar Innovations, Inc. (Bensalem, PA) in 1994: 1 510(k) clearance. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Telstar Innovations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Telstar Innovations, 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 “Telstar”

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