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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 a medical device manufactured by Precise Light Surgical. It received FDA 510(k) clearance on 2016-06-02 under approval 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. It is manufactured by Precise Light Surgical. The 510(k) number is K160012.

When was O-pel Laser and families of probe delivery devices approved by the FDA?

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

What company makes O-pel Laser and families of probe delivery devices?

O-pel Laser and families of probe delivery devices is manufactured by Precise Light Surgical.

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

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Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025) PMID: 37459057 Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. JAMA internal medicine (2023) PMID: 34430278 Preparation and sterilization of an implantable drug-delivery microdevice for clinical use. MethodsX (2021) PMID: 31312553 An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices. Cureus (2019)

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Official Source

View on FDA Database →

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

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