HIGHERDOSE Body Sculptor (Model: GS-03)
K-Number: K252603 · 2026-01-28
Decision Date2026-01-28
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HIGHERDOSE Body Sculptor (Model: GS-03) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under approval number K252603. 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 HIGHERDOSE Body Sculptor (Model: GS-03)?
HIGHERDOSE Body Sculptor (Model: GS-03) is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252603.
When was HIGHERDOSE Body Sculptor (Model: GS-03) approved by the FDA?
HIGHERDOSE Body Sculptor (Model: GS-03) received FDA 510(k) clearance on 2026-01-28, under approval number K252603.
What company makes HIGHERDOSE Body Sculptor (Model: GS-03)?
HIGHERDOSE Body Sculptor (Model: GS-03) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..
What is the FDA product code for HIGHERDOSE Body Sculptor (Model: GS-03)?
The FDA product code for HIGHERDOSE Body Sculptor (Model: GS-03) is OHS.
Other Devices by Shenzhen Kaiyan Medical Equipment Co., Ltd.
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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.