CoolTone
K-Number: K253408 · 2026-01-16
Device Summary
Frequently Asked Questions
What is the CoolTone?
CoolTone is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K253408.
When did CoolTone receive FDA 510(k) clearance?
CoolTone received FDA 510(k) clearance on 2026-01-16, under 510(k) number K253408.
Who is the listed applicant for CoolTone?
The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoolTone?
The FDA product code for CoolTone is NGX.
Other records listing Zimmer Medizinsysteme GmbH as applicant
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.
Related Devices (Code: NGX)
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.
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.