Manufacturer
Mvitro Co., Ltd.ORTIV (ORTIV-BL, ORTIV-WH)
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
1LMT-3000
K241646 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241646 as a predicate