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ORTIV (ORTIV-BL, ORTIV-WH)

Mvitro Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Mvitro Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241646
Device name
ORTIV (ORTIV-BL, ORTIV-WH)
Company
Mvitro Co., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-07
Decision date
2024-11-01
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.

Intended Use

The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.

Device Description

ORTIV laser lancet is a portable, battery-operated laser lancing device. The laser is a pulsed Erbium YAG (ER: YAG). It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.

Summary parsed at:2026-06-01 05:28:36 UTC

Predicate devices

1

K241646 references 1 predicate/reference device

Cited as predicate

0

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