GREEN— 510(k) K252060

Name: FDA 510(k) clearance K252060
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Substantially Equivalent

Phasor Health, LLC

FDA 510(k) clearance K252060 for GREEN, Substantially Equivalent on 2025-10-31. Applicant: Phasor Health, LLC. Device class: 2.

Clearance details

Applicant: Phasor Health, LLC
Product code: Code HBE
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2025-07-01
Decision date: 2025-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K252662 — UniBur2025-09-19
K251433 — Surgify Halo (8 models)2025-06-04
K250380 — Surgify Halo (5 models)2025-03-13

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.