K-number	K231148
Device name	ScleroSafe 150 mm, ScleroSafe 350 mm
Applicant	Vvt Medical , Ltd.
Product code	KRA
Device class	Class II
Decision date	Jun 20, 2023
Decision	Substantially Equivalent
Regulation	870.1210

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Source

View the full FDA submission: accessdata.fda.gov

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ScleroSafe 150 mm, ScleroSafe 350 mm

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ScleroSafe 150 mm, ScleroSafe 350 mm