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)

VX650

K-Number: K202221 · 2021-01-29

ApplicantLuneau Technology Operations
Decision Date2021-01-29
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VX650 is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Technology Operations. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202221. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VX650?

VX650 is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Luneau Technology Operations. The 510(k) number is K202221.

When did VX650 receive FDA 510(k) clearance?

VX650 received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202221.

Who is the listed applicant for VX650?

The FDA 510(k) record lists Luneau Technology Operations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VX650?

The FDA product code for VX650 is HKI.

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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.

↑