Manufacturer
CAO Group, Inc.Sterling Supreme Diode Laser
Country / Region:United States (US)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
- K171986
- Device name
- Sterling Supreme Diode Laser
- Company
- CAO Group, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-07-03
- Decision date
- 2017-09-22
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue; 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Intended Use
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue; 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
Device Description
The Sterling Supreme Diode Laser features a working beam output wavelength of 810±10 nm and output power ranging from 0.1 - 3.0 watts. The aiming beam output power is < 3mW with a wavelength of 650±20 nm. It utilizes an AlGaAs Diode laser source and is activated by a wireless foot pedal. The device has digital emission control with selectable fixed pulse durations and is cooled by a heatsink/fan. It operates on 100-240 VAC @ 47-63 Hz, 1.6A. The user interface is a color LCD touch screen, and the laser delivery system uses a sheathed quartz optical fiber. The handpiece design includes a stainless steel inner stem and a removable, sterilizable anodized aluminum outer sleeve. Patient contact articles are single-use disposable tips made of silica quartz, stainless steel, and ABS plastic.
Summary parsed at:2026-06-01 06:00:29 UTC
Predicate devices
1—
—
Not ingested
K171986 references 1 predicate/reference device
Cited as predicate
1Sterling Supreme Diode Laser
1 submission cite K171986 as a predicate
