Lasertripter Miniscope

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K874858 ↗

FDA Product Code

ODF

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Candela Cryo-Probe Holder

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• Candela Sptl Pulsed Dye Lasers

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• Candela Q-Switched Alexandrite Laser

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See all devices from Candela Laser Corp. →

• What is the Lasertripter Miniscope used for?

  The Lasertripter Miniscope is a laser-based endoscopic system designed for minimally invasive lithotripsy procedures, specifically used in the fragmentation of urinary tract stones within gastroenterology and urology clinical settings.

• How is the Lasertripter Miniscope supplied and what does it include?

  The device is supplied with a carrying case and optical system as indicated by the manufacturer reference CL408007, intended for use in clinical environments.

• Is the Lasertripter Miniscope a single-use or reusable device?

  The provided data does not specify whether the Lasertripter Miniscope is single-use or reusable; therefore, reuse status cannot be determined from the available information.

• What regulatory pathway was used for the Lasertripter Miniscope?

  The Lasertripter Miniscope was cleared via the FDA 510(k) process under K874858, with a decision date of February 19, 1988, and classified as a Class II device under regulation number 876.1500.

• What are the key identifiers for the Lasertripter Miniscope?

  The device is identified by the name Lasertripter Miniscope, manufacturer Candela Laser Corp., manufacturer reference CL408007, FDA 510(k) number K874858, and product code ODF under the Gastroenterology-Urology advisory committee.