Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MMSphere

K-Number: K190443 · 2019-06-24

Decision Date2019-06-24
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MMSphere is a medical device manufactured by Galactic Beauty, LLC. It received FDA 510(k) clearance on 2019-06-24 under approval number K190443. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MMSphere?

MMSphere is a medical device that received FDA 510(k) clearance on 2019-06-24. It is manufactured by Galactic Beauty, LLC. The 510(k) number is K190443.

When was MMSphere approved by the FDA?

MMSphere received FDA 510(k) clearance on 2019-06-24, under approval number K190443.

What company makes MMSphere?

MMSphere is manufactured by Galactic Beauty, LLC.

What is the FDA product code for MMSphere?

The FDA product code for MMSphere is OHS.

Related Devices (Code: OHS)

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.