FDA 510(k)

CURVE Laser System

K-Number: K170709 · 2017-06-06

Decision Date2017-06-06

Product CodeOLI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CURVE Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Yolo Medical, Inc.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170709. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURVE Laser System?

CURVE Laser System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Yolo Medical, Inc.. The 510(k) number is K170709.

When did CURVE Laser System receive FDA 510(k) clearance?

CURVE Laser System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170709.

Who is the listed applicant for CURVE Laser System?

The FDA 510(k) record lists Yolo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURVE Laser System?

The FDA product code for CURVE Laser System is OLI.

Related Devices (Code: OLI)

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.