DeviceClearance

Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)— 510(k) K252971

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K252971 for Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories), Substantially Equivalent on 2026-03-17. Applicant: C.R. Bard, Inc.. Device class: 2.

Summary

C.R. Bard's record covers the Elyra Thulium Fiber Laser System and the Elyra Plus Thulium Fiber Laser System, with lasers, fibers, and accessories. They're filed under GEX, powered laser surgical instruments.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

C.R. Bard filed from Covington, Georgia. The decision came 181 calendar days after receipt (September 17, 2025 to March 17, 2026).

Clearance details

Applicant
C.R. Bard, Inc.
Product code
Product code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Covington, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.