SKIA-Head (Model: SKIA-ST00)
K-Number: K253486 · 2026-02-23
ApplicantSkia, Inc.
Decision Date2026-02-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SKIA-Head (Model: SKIA-ST00) is a medical device manufactured by Skia, Inc.. It received FDA 510(k) clearance on 2026-02-23 under approval number K253486. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SKIA-Head (Model: SKIA-ST00)?
SKIA-Head (Model: SKIA-ST00) is a medical device that received FDA 510(k) clearance on 2026-02-23. It is manufactured by Skia, Inc.. The 510(k) number is K253486.
When was SKIA-Head (Model: SKIA-ST00) approved by the FDA?
SKIA-Head (Model: SKIA-ST00) received FDA 510(k) clearance on 2026-02-23, under approval number K253486.
What company makes SKIA-Head (Model: SKIA-ST00)?
SKIA-Head (Model: SKIA-ST00) is manufactured by Skia, Inc..
What is the FDA product code for SKIA-Head (Model: SKIA-ST00)?
The FDA product code for SKIA-Head (Model: SKIA-ST00) is LLZ.
Related Devices (Code: LLZ)
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.