(54 days)
Not Found
Sirona SIROLaser Advance (K0092660)
No
The device description and intended use focus on the laser's physical properties and modes of operation (continuous wave, chopped mode) for soft tissue surgery. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The "predetermined settings for different indications" are likely pre-programmed parameters based on clinical experience, not learned from data.
Yes
Explanation: The "Intended Use / Indications for Use" section lists numerous diagnostic and therapeutic applications involving soft tissue treatment, including incision, excision, hemostasis, coagulation, vaporization, removal of diseased tissue, and treatment of various oral conditions and lesions.
No
The device description and intended use indicate that the SIROLaser Advance is a surgical tool for cutting, ablating, and treating oral soft tissues, not for diagnosing conditions. It performs therapeutic procedures.
No
The device description explicitly states it is a "Diode Laser System" comprised of a "laser unit with handpiece, laser fibers... bendable tips, and a wireless foot control," which are all hardware components. The performance studies also mention validation testing of both hardware and software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential recipients, or to monitor therapeutic measures.
- Device Function: The SIROLaser Advance is a surgical laser system used for direct treatment of soft tissue in the mouth. It performs procedures like cutting, coagulation, and vaporization.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens (blood, tissue, etc.) outside of the body. Its function is to directly interact with and modify tissue within the patient.
Therefore, the SIROLaser Advance falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Models: Sirolaser Advance and SIROLaser Xtend Upgrade
Intended Use: Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue
Indications for Use: Marginal and interdental gingival and epithclial lining of free gingiva; 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 deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions ; papillectomy ; vestibulonlasty ; excision of lesions ; exposure of unerupted/partially erupted teeth ; removal of hypomlastic tissues ; treatment of aphthous ulcers ; leukoplakia ; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; anderlar debridement (removal of diseased, inflamed and necrosed soft Usous the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth index, 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.
Models: SIROLaser Xtend and FONALaser
Intended Use: Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue
Indications of use: marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectony; gingivoplasty; gingival troughing; crown lengthening; hemostasis of goodsite; removal of granulation tissue ; incisions and draining of abscesses lissue rctraction for impressions ; papillectomy ; vestibuloplasty ; crecisions ; exposure of unerupted/partially erupted teeth ; removal of hyperplastic tossues ; treatment of aphthous ulcers ; leukoplakia ; Laser removal of diseased, infouced, inflamed and necrosed soft tissue within the periodontal pocket, moodlar debridement (removal of diseased, infected, inflamed and necrosed soft tssue 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control.
The SIROLascr Advance has the following basic functions
- Ability to cmit laser radiation either in continuous wave mode (cw) or o chopped mode
- Sctup and display of treatment parameters: P power., treatment time, o chop frequency o o duty cycle
- Selection of predetermined settings for different indications
- Upgradeable firmware
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to validate the safety and effectiveness of the SIROLascr Advance includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SIROLaser Advance, Biolase iLase
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Sirona SIROLaser Advance (K0092660)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
10375 3
FEB 15 2011
510(k) Summary
for
Siroma Demtal Systems SIROLaser Advance
下一 SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: August 4, 2010
ア DEVICE NAME
Proprietary Name:
Models:
SIROLaser Advance SIROLaser Xtend upgraded SIROLaser Xtend
SIROLaser Advance
FONALaser
Common / usual name: Classification Names:
Dental Soft Tissue Laser Laser instrument, surgical, powered
です PREDICATE DEVICE
SIROLaser Advance, Biolase iLase
在 INTENDED USE
Models: Sirolaser Advance and SIROLaser Xtend Upgrade
Intended Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue
Indications for Use:
Sirona Dental traditional 510(k) SummaryAugust 4, 2010 SIROLaser Advance
· Page i of 3
1
Marginal and interdental gingival and epithclial lining of free gingiva;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 deseased epithelial lining ; incisions and draining of abscesses; tissue retraction for impressions ; papillectomy ; vestibulonlasty ; excision of lesions ; exposure of unerupted/partially erupted teeth ; removal of hypomlastic tissues ; treatment of aphthous ulcers ; leukoplakia ; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; anderlar debridement (removal of diseased, inflamed and necrosed soft Usous the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth index, 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.
Models: SIROLaser Xtend and FONALaser
Intended Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue
Indications of use:
marginal and interdental gingival and epithelial lining of free gingiva; frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectony; gingivoplasty; gingival troughing; crown lengthening; hemostasis of goodsite; removal of granulation tissue ; incisions and draining of abscesses lissue rctraction for impressions ; papillectomy ; vestibuloplasty ; crecisions ; exposure of unerupted/partially erupted teeth ; removal of hyperplastic tossues ; treatment of aphthous ulcers ; leukoplakia ; Laser removal of diseased, infouced, inflamed and necrosed soft tissue within the periodontal pocket, moodlar debridement (removal of diseased, infected, inflamed and necrosed soft tssue 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. Models: Sirolaser Advance and SIROLaser Xtend Upgrade
い DEVICE DESCRIPTION
Sirona Dental traditional 510(k) SummaryAugust 4, 2010 SIROLaser Advance
· Page 2 of 3
2
!J3753
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control.
The SIROLascr Advance has the following basic functions
- Ability to cmit laser radiation either in continuous wave mode (cw) or o chopped mode
- Sctup and display of treatment parameters: P
- o power.
- treatment time, o
- chop frequency o
- o duty cycle
- Selection of predetermined settings for different indications ନ
- ନ Upgradeable firmware
乐. BASIS FOR SUBSTANTIAL EQUIVALENCE
The Sirona Dental Systems SIROLaser Advance Device is substantially equivalent to Sirona SIROLaser Advance (K0092660) and Biolase iLasc. Performance testing to validate the safety and effectiveness of the SIROLascr Advance includes electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
· Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Sirona Dental Systems GmbH % TUV SUD America Inc. Mr. Olaf Teichert 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
FEB 15 201
Re: K103753
Trade/Device Name: SIROLaser Advance Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 02, 2011 Received: February 04, 2011
Dear Mr. Teichert:
1
:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. the first to the state of the state of the subject to the country of the country of the county of
.
Carlos Concession Comers
4
Page 2 – Mr. Olaf Teichert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal_roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ky B. n he
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K1J375'3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SIROLaser Advance
Models: Sirolaser Advance and SIROLaser Xtend Upgrade
Indications for Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft ന്ട്ടുമെന്നും I and interdental gingival and epithelial lining of free gingiva: frenctomy; biopsy; biopsy; operculectory; Implant recovery; gingivectory; gingival troughing; crown lengthening; crown lengthening; dessect sait divine site; removal of granulation tissue ; laser assisted flap surgery; debridement of deseased epithelial lining ; incisions and draining of absesses; tissue retraction for impressions ; papillectory ; vestibuloplasty ; excision of lesions ; exposure of unerupted/partially enpred teeth ; removal of hyperplastic tissues ; treatment of aphthous ulcers ; loukoplakia ; Laser removal of diseased, infected, inflamed inforced information the periodontal pocker, Sulcular debridement (removal of including and necrosed soft tissue in the periodontal pocket to improve clinical indices mulpatems wel at meet gingival bleeding index, probe depth, attachment loss and tooth inability), pulpotomy as adjunct to root canal therapy, Fibroopa, attachinen Toss and Tooli Incision and excision, Treatment of canker sores; herpetic ulcers of the oral mucosa; Laser soft tissue curctage; Recustion of gingival hypertrophy; .
Device Name: SIROLaser Advance
Models: SIROLaser Xtend and FONALaser
Intra- and extra-oral surgery including incision excision hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenctorny; frenctorny; frenctorny; biopsy, operculectory; implant recovery; gingivectory; gingival troughing; grown lengthening; hemostasis of donor site; removal of granulation tissue ; incisions and draining of abscesses; tissue retraction for impressions ; papillectorny ; vestibuloplasty ; excision of lesions ; exposure of uncrupted partially enipted tech ; removal of hyperplastic tissues ; treatment of aphthous ulcers ; leukoplakia ; Laser removal of diseased, inflamed and necrosed soft tissue within the priodontal pocket; Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the derth, attactures 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;
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE Page I of 1
Nil A.S. Qul for mkn
(Division Sign Off)
ion of Surgical. Orthopedic. and Restorative Devices
Sirona Dental Systems traditional 510(k) SIROLaser Advance
August 4, 2010