LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
K-Number: K231555 · 2023-07-27
ApplicantiSMART Developments, Ltd.
Decision Date2023-07-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is a medical device manufactured by iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2023-07-27 under approval number K231555. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by iSMART Developments, Ltd.. The 510(k) number is K231555.
When was LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) approved by the FDA?
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) received FDA 510(k) clearance on 2023-07-27, under approval number K231555.
What company makes LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?
LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is manufactured by iSMART Developments, Ltd..
What is the FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))?
The FDA product code for LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) is OHS.
Other Devices by iSMART Developments, Ltd.
Related Devices (Code: OHS)
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.