Lasersonics Ultraline III Sterile Disposable Fiber

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951215 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Lasersonics Parascan Dosimeter Device

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• Lasersonics Nd:yag Cylindrically Diffusing Sterile Disposable Fiber

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See all devices from Heraeus Surgical, Inc. →

• What is the Lasersonics Ultraline III Sterile Disposable Fiber used for?

  It is used to deliver laser energy during general and plastic surgery procedures when connected to compatible surgical laser systems, enabling precise tissue interaction in clinical settings.

• How is the Lasersonics Ultraline III Sterile Disposable Fiber supplied and is it reusable?

  The device is supplied sterile and is intended for single-use only; it must not be reprocessed or reused due to risks of contamination, fiber degradation, and compromised laser delivery performance.

• What regulatory authorization does the Lasersonics Ultraline III Sterile Disposable Fiber have?

  It has received FDA 510(k) clearance under product code GEX, with a substantially equivalent determination, allowing its legal marketing and use in the United States for the specified surgical applications.