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

FDA 510(k)

LIPOcel

K-Number: K181896 · 2019-10-18

Decision Date2019-10-18
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIPOcel is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K181896. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPOcel?

LIPOcel is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K181896.

When did LIPOcel receive FDA 510(k) clearance?

LIPOcel received FDA 510(k) clearance on 2019-10-18, under 510(k) number K181896.

Who is the listed applicant for LIPOcel?

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

What is the FDA product code for LIPOcel?

The FDA product code for LIPOcel is OHV.

Other records listing Jeisys Medical, Inc. 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.

View all 13 devices →

Related Devices (Code: OHV)

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.