FDA 510(k)

Onycho Laser V

K-Number: K241116 · 2024-07-22

Decision Date2024-07-22

Product CodePDZ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Onycho Laser V is the device name listed in this FDA 510(k) record. The listed applicant is Terasysd&C, Inc.. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K241116. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Onycho Laser V?

Onycho Laser V is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Terasysd&C, Inc.. The 510(k) number is K241116.

When did Onycho Laser V receive FDA 510(k) clearance?

Onycho Laser V received FDA 510(k) clearance on 2024-07-22, under 510(k) number K241116.

Who is the listed applicant for Onycho Laser V?

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

What is the FDA product code for Onycho Laser V?

The FDA product code for Onycho Laser V is PDZ.

Related Devices (Code: PDZ)

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.

K253960Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTD K211265TFX-LT2000 Therapy LightToefx, Inc.K221363AF LaserShenB Co., Ltd.K190034REMY Medical Therapy Laser SystemFootdocprenur, LLC K153164LunulaLaserErchonia Medical, Inc.

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.