SIROLaser Advance+

Dentsply Sirona

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

3

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K170500
Device name
SIROLaser Advance+
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-02-21
Decision date
2017-05-16
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The SIROLaser Advance is intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: The SIROLaser Advance is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: The SIROLaser Advance is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

Intended Use

The SIROLaser Advance+ is intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: The SIROLaser Advance+ is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: The SIROLaser Advance+ is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.

Device Description

The SIROLaser Advance+ is a solid state laser in which laser energy is generated by internal diodes. The laser output energy of the device is in the infrared and red spectra at wavelengths of 970 nm and 660 nm, respectively. The output settings of the SIROLaser Advance+ can be adjusted by the user and also features preset operating modes which are designed to correspond with its proposed surgical, periodontic, and endodontic applications. SIROLaser Advance+ primarily consists of a laser control unit with graphical touch screen user interface, a laser handpiece, and single-use, disposable, 'EasyTip' laser fiber guides (for surgical applications), as well as, reusable 'MultiTip' light guides (for non-contact, low-power, 'soft laser' applications). The laser control unit contains the 970 nm and 660 nm laser diodes, electronic hardware, touchscreen graphical user interface, and software to control the laser functionality. The SIROLaser Advance+ handpiece assembly consists of an internal handpiece body with laser activation finger switch. The handpiece includes a removable stainless steel outer sleeve which can be cleaned and sterilized between patient procedures. The SIROLaser Advance+ is also offered with an optional wireless footswitch.

Summary parsed at:2026-06-01 05:59:47 UTC

Predicate devices

3

K170500 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K170500 as a predicate