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Yolo Curve

by Yolo Medical, Inc.

510(k) K110342

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110342 Date22 Aug 2011ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Yolo Curve is a non-invasive, hand-held infrared lamp system designed for topical heat therapy. The system comprises a drive unit, power supply, controls, and treatment probes containing visible radiating elements.

This device is cleared through the FDA 510(k) pathway under K110342. It features a 4-paddle system and is categorized as a Class 2 Physical Medicine device.

Other devices from Yolo Medical, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Yolo Curve?

    The Yolo Curve is a non-invasive, hand-held infrared lamp system specifically designed to provide topical heat therapy. It utilizes visible radiating elements housed within treatment probes to deliver this therapy.

  • What components are included with the Yolo Curve system?

    The system is supplied as a complete unit consisting of a drive unit, a power supply, control interfaces, and a 4-paddle system containing the visible radiating elements used for treatment.

  • What is the regulatory status of this device?

    The Yolo Curve has been cleared through the FDA 510(k) pathway under K110342. It is categorized as a Class 2 Physical Medicine device, having been determined to be substantially equivalent to existing devices.