Manufacturer
Lutronic GlobalLaseMD LEO Laser System
Country / Region:United States (US)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
- K192331
- Device name
- LaseMD LEO Laser System
- Company
- Lutronic Global
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-08-27
- Decision date
- 2019-11-12
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Skin resurfacingPigment treatmentVascular treatmentOther
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The LaseMD LEO 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 LEO 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 LEO 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 LCD touch screen gives the user control over the necessary laser system parameters. The LaseMD LEO Laser System is equipped with a 658 nm aiming beam.
Summary parsed at:2026-06-01 05:55:49 UTC
Predicate devices
2—
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Not ingested
LASEMD Laser System
K192331 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K192331 as a predicate