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LaseMD LEO Laser System

Lutronic Global

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Lutronic Global
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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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

K192331 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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