Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
K-Number: K260093 · 2026-03-31
ApplicantVATECH Co., Ltd.
Decision Date2026-03-31
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2026-03-31 under approval number K260093. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) is a medical device that received FDA 510(k) clearance on 2026-03-31. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K260093.
When was Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) approved by the FDA?
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) received FDA 510(k) clearance on 2026-03-31, under approval number K260093.
What company makes Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) is manufactured by VATECH Co., Ltd..
What is the FDA product code for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)?
The FDA product code for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) is OAS.
Other Devices by VATECH Co., Ltd.
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
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.