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)

Vision

K-Number: K212770 · 2021-12-21

ApplicantSoftsmile, Inc.
Decision Date2021-12-21
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vision is a medical device manufactured by Softsmile, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K212770. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vision?

Vision is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Softsmile, Inc.. The 510(k) number is K212770.

When was Vision approved by the FDA?

Vision received FDA 510(k) clearance on 2021-12-21, under approval number K212770.

What company makes Vision?

Vision is manufactured by Softsmile, Inc..

What is the FDA product code for Vision?

The FDA product code for Vision is PNN.

Related Devices (Code: PNN)

K1520863Shape Ortho System3Shape A/S K163677Ortho System3Shape A/S K162850GuideMia Ortho+Guidemia Technologies, LLC K181112Orchestrate 3DOrchestrate 3D K180941Ortho System3Shape A/S K171634Ortho System3Shape A/S

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.

↑