Manufacturer
Lutronic CorporationLASEMD Laser System
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
- K171009
- Device name
- LASEMD Laser System
- Company
- Lutronic Corporation
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-04-04
- Decision date
- 2017-06-23
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Intended Use
The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Device Description
The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.
Summary parsed at:2026-06-01 06:00:06 UTC
Predicate devices
1—
—
Not ingested
K171009 references 1 predicate/reference device
Cited as predicate
4Joule System
LaseMD LEO Laser System
Lavieen
The Botticelli (Model: Athena)
4 submissions cite K171009 as a predicate