Manufacturer
Lameditech Co. , Ltd.LMT-3000
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K172818
- Device name
- LMT-3000
- Company
- Lameditech Co. , Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-18
- Decision date
- 2018-03-07
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples. The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
Intended Use
The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples. The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purpose. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
Device Description
The LMT-3000 lancing device uses a battery-powered laser beam (Er:YAG laser technology), which makes a tiny hole in the skin to obtain a capillary blood sample. The LMT-3000 ablates the epidermis and a thin layer of papillary dermis with minimal photothermal and photomechanical damage to the surrounding tissue.
Summary parsed at:2026-06-01 05:56:25 UTC
Predicate devices
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Not ingested
K172818 references 1 predicate/reference device
Cited as predicate
1ORTIV (ORTIV-BL, ORTIV-WH)
1 submission cite K172818 as a predicate