Manufacturer
Focus Medical, LLCLite Touch
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
- K152737
- Device name
- Lite Touch
- Company
- Focus Medical, LLC
- 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
2MCL 31 Dermablate
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Not ingested
K152737 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 K152737 as a predicate