TOMi Scope
K-Number: K191804 · 2019-12-05
ApplicantPhotonicare, Inc.
Decision Date2019-12-05
Product CodeQJG
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TOMi Scope is a medical device manufactured by Photonicare, Inc.. It received FDA 510(k) clearance on 2019-12-05 under approval number K191804. The device is classified under product code QJG. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TOMi Scope?
TOMi Scope is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Photonicare, Inc.. The 510(k) number is K191804.
When was TOMi Scope approved by the FDA?
TOMi Scope received FDA 510(k) clearance on 2019-12-05, under approval number K191804.
What company makes TOMi Scope?
TOMi Scope is manufactured by Photonicare, Inc..
What is the FDA product code for TOMi Scope?
The FDA product code for TOMi Scope is QJG.
Other Devices by Photonicare, Inc.
Related Devices (Code: QJG)
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.