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
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K181614
- 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
- 2018-06-19
- Decision date
- 2019-09-10
- 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.
Summary parsed at:2026-06-01 05:54:41 UTC
Predicate devices
1Sterling Supreme Diode Laser
K181614 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K181614 as a predicate