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FDA 510(k)

O-pel Laser and families of probe delivery devices

K-Number: K160012 · 2016-06-02

ApplicantPrecise Light Surgical
Decision Date2016-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

O-pel Laser and families of probe delivery devices is the device name listed in this FDA 510(k) record. The listed applicant is Precise Light Surgical. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160012. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O-pel Laser and families of probe delivery devices?

O-pel Laser and families of probe delivery devices is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Precise Light Surgical. The 510(k) number is K160012.

When did O-pel Laser and families of probe delivery devices receive FDA 510(k) clearance?

O-pel Laser and families of probe delivery devices received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160012.

Who is the listed applicant for O-pel Laser and families of probe delivery devices?

The FDA 510(k) record lists Precise Light Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-pel Laser and families of probe delivery devices?

The FDA product code for O-pel Laser and families of probe delivery devices is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06958731In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled TrialENROLLING_BY_INVITATION

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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