Lite Touch

Focus Medical, LLC

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

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K152737
Device name
Lite Touch
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-09-23
Decision date
2016-06-29
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

• Dermatology
• Cosmetic surgery
• Plastic and general surgery
• Oral surgery
• Gynecology
• Otorhinolaryngology
• Podiatry

Intended Use

Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Oral surgery; Gynecology; Otorhinolaryngology; Podiatry.

Device Description

The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Oral surgery; Gynecology; Otorhinolaryngology; and Podiatry. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.

Summary parsed at:2026-06-01 06:05:18 UTC

Predicate devices

2

K152737 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K152737 as a predicate