Looper (Model: ZX-579S)
K-Number: K202055 · 2021-04-16
ApplicantHeat IN A Click, LLC
Decision Date2021-04-16
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Looper (Model: ZX-579S) is a medical device manufactured by Heat IN A Click, LLC. It received FDA 510(k) clearance on 2021-04-16 under approval number K202055. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Looper (Model: ZX-579S)?
Looper (Model: ZX-579S) is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by Heat IN A Click, LLC. The 510(k) number is K202055.
When was Looper (Model: ZX-579S) approved by the FDA?
Looper (Model: ZX-579S) received FDA 510(k) clearance on 2021-04-16, under approval number K202055.
What company makes Looper (Model: ZX-579S)?
Looper (Model: ZX-579S) is manufactured by Heat IN A Click, LLC.
What is the FDA product code for Looper (Model: ZX-579S)?
The FDA product code for Looper (Model: ZX-579S) is OLP.
Other Devices by Heat IN A Click, LLC
Related Devices (Code: OLP)
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.