Sterling 5W Diode Laser

CAO Group, Inc.

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

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K160413
Device name
Sterling 5W Diode Laser
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-02-16
Decision date
2016-09-21
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 Diode Laser is indicated for:

Dental soft tissue indications:

Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue, excision and biopsy, gingivectomy and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.

Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

Intended Use

The Sterling Diode Laser is indicated for: Dental soft tissue indications: Dental, oral and soft tissue surgery including: Sulcular debridement of diseased or fibrous tissue, excision and biopsy, gingivectomy and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation. Laser periodontal procedures, including: Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

Device Description

The Sterling Diode Laser is a powered laser surgical instrument designed for dental soft tissue procedures. It operates at a wavelength of 810±10 nm and has a beam output power ranging from 0.5 to 5.0 watts. The device features a wireless foot pedal for activation, digital emission control with a fixed pulse duration of 0.05 seconds at 10Hz, and utilizes a quartz optical fiber for laser delivery. The cooling method includes a heatsink and fan air cooling system. The device is powered by an electrical input of 100-240 VAC at 47-63 Hz. The user interface consists of an illuminated LED display and a membrane keypad. The dimensions of the device are 9" x 6" x 5" and it weighs 5.0 lbs.

Summary parsed at:2026-06-01 06:05:56 UTC

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