The SIROLaser Advance+ is intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; 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, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including 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 temperary 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 660nm, 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SIROLaser Advance+ device, which is an laser surgical instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and efficacy through extensive clinical trials with specific acceptance criteria related to disease detection or treatment outcomes.

Therefore, the information you're looking for, such as a table of acceptance criteria with reported device performance related to a clinical outcome, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed training set information, is not typically included or required in this type of regulatory submission because the device itself does not make a diagnostic or prognostic claim that would necessitate such studies.

Instead, the "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through non-clinical performance data, primarily focusing on engineering, safety, and operational specifications.

Here's a breakdown based on the provided text, explaining why certain requested information is absent:

Acceptance Criteria and Study Supporting Device Equivalence (Not Clinical Performance)

The "acceptance criteria" in this context refer to the successful demonstration of equivalence to predicate devices and adherence to relevant safety and performance standards. The "study" refers to the non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on safety and operational performance, there isn't a direct equivalent to a clinical "acceptance criteria" table and reported "device performance" in terms of clinical accuracy (e.g., sensitivity, specificity for a diagnostic device).

Instead, the performance verification is against engineering standards and specific operational specifications, which are compared to predicate devices for substantial equivalence.

Acceptance Criteria (General for 510(k))	Reported Device Performance (from Non-Clinical Data)
Safety and Electrical Standards	- Conformity to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).- Conformity to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
Laser Safety Standards	- Conformity to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements).- Conformity to IEC 60601-2-22 (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
Usability	- Usability study conducted in conformity with IEC 62366 (Medical devices – Application of usability engineering to medical devices).
Biocompatibility	- Biocompatibility assessment of patient contacting components according to ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for cytotoxicity).
Software Validation	- Validation of the device's software in conformity with IEC 62304 (Medical device software – Software lifecycle processes).
Functional Equivalence	- Wavelengths: 970 nm (-10 nm/+15 nm) & 660 nm (+/- 5 nm), comparable to predicates (Epic 10: 940 nm; SIROLaser Advance: 970 nm; THOR VR: 660 nm).- Optical Power: 970 nm: 0.2W-7.0W (CW), 14W (peak); 660 nm: 25mW, 50mW, 100mW. Comparable to predicates (Epic 10: 10W; SIROLaser Advance: 7.0W, 14W peak; THOR VR: 30mW, 75mW, 200mW).- Emission Modalities & Pulse Duration: Continuous Wave, Chopped (1Hz-10kHz), Peak Pulse (1.5kHz-20kHz), comparable to predicates.- Aiming Beam: 660 nm (+/- 5 nm), 1mW (max), comparable to predicates (625-670 nm, 1mW max).- Fiber Diameter: 200 µm, 320 µm, comparable to predicates (200 µm, 300 µm, 400 µm).- User Interface: Color touch screen graphical user interface, same as primary predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "No human clinical data was included to support substantial equivalence." Therefore, there is no "test set" in the sense of patient data for clinical performance evaluation. The "test set" here refers to the actual device units tested under various engineering standards and for biocompatibility. The provenance would be the Dentsply Sirona testing labs or certified third-party testing facilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. Since no human clinical data was included, there was no need for experts to establish ground truth on patient cases. The qualification for the engineers and technicians performing the non-clinical tests would be their certifications in electrical, laser, mechanical, and software engineering, as well as biocompatibility.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert opinions on patient data. This was not a clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers" interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a hardware device (laser) with accompanying software for control. "Standalone performance" in this context refers to the device's adherence to its specified performance parameters (e.g., power output, wavelength stability, safety features) without human intervention in operating the device itself during these tests, which were performed per the listed IEC standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this 510(k) submission, the "ground truth" for the non-clinical tests is:

Engineering Specifications and International Standards: The device's performance (e.g., laser power, wavelength, electrical safety, EMC, software functionality) is compared against pre-defined, industry-accepted standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 62366, IEC 62304) and the manufacturer's own design specifications.
Biocompatibility Standards: The patient-contacting components are tested against ISO 10993-5 (cytotoxicity) for biological safety.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of machine learning or AI models, as this device does not incorporate such algorithms for diagnostic or prognostic purposes.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set as defined for AI or machine learning, this question does not apply.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 16, 2017

Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404

Re: K170500 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, ILY Dated: February 18, 2017 Received: February 21, 2017

Dear Karl Nittinger:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) к170500

Device Name: SIROLaser Advance+

Indications for Use (Describe)

Whitening: The SIROLaser Advance+ is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Image /page/3/Picture/1 description: The image shows the Dentsply Sirona logo. The logo consists of a stylized, abstract symbol on the left, resembling a curved shape. To the right of the symbol are the words "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font.

SECTION 5. 510(k) SUMMARY for

SIROLaser Advance+

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: 15 May 2017

2. Device Name:

Proprietary Name: SIROLaser Advance+ ● .
- Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology.
CFR Number: 21 CFR 878.4810 ●
Device Class: Class II ● Product Code: . GEX (Powered Laser Surgical Instrument) ILY ( Lamp, Infrared, Therapeutic Heating)

3. Predicate Device:

The predicate devices for the SIROLaser Advance+ are:

Primary Predicate Device Name	510(k)	Company Name
Epic 10	K121286	Biolase Technology, Inc.

Additional Predicate Devices	510(k)	Company Name
SIROLaser Advance	K103753	Sirona Dental Systems GmbH
THOR VR Single Diode Laser Treatment Probe	K070024	THOR International

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4. Description of Device:

న్. 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; 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, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, 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 indicted 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.

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Substantial Equivalence: 6.

The SIROLaser Advance+ has the same intended use as the predicate device. Both the SIROLaser Advance+ and the predicate device are intended as powered laser surgical instruments as well as to provide topical heating to soft tissues for therapeutic purposes under 21 CFR 878.4810 and 21 CFR 890.5500, respectively.

The SIROLaser Advance+ and the predicate device both generate laser energy via solid state LED technology. As do the predicate devices, the SIROLaser Advance+ emits laser light energy in both the infrared and red spectra.

The SIROLaser Advance+ and the predicate device are operated for surgical applications using handpieces to which single-use laser fiber tips are attached. For low-level laser therapy applications, both the SIROLaser Advance+ and the predicate device offer non-contact handpieces.

Detailed comparison of the intended use, indications for use, and design of the SIROLaser Advance+ and the predicate devices is presented in Tables 6.1 and 6.2.

Proposed DeviceSIROLaser Advance+	Primary Predicate DeviceEpic 10(K121286)	Predicate DeviceSIROLaser Advance(K103753)	Predicate DeviceTHOR VR SingleDiode LaserTreatment Probe(K070024)
Surgical indications for Use:
Intended for intra- and extra-oral surgery including incision,excision, hemostasis,coagulation and vaporization ofsoft tissue including marginaland inter-dental and epitheliallining of free gingiva and isindicated for:	Incision, excision, vaporization, ablationand coagulation of oral tissues includingmarginal and inter-dental gingiva andepithelial lining of free gingiva and thefollowing specific indications:	Intended for intra- and extra-oralsurgery including incision,excision, hemostasis, coagulationand vaporization of soft tissueincluding marginal and inter-dental and epithelial lining of freegingiva and is indicated for:	N/A
frenectomy; frenotomy;	frenectomy; frenotomy	frenectomy; frenotomy;	N/A
biopsy; operculectomy;	excisional and incisional biopsies;operculectomy:	biopsy; operculectomy;	N/A
implant recovery;	implant recovery:	implant recovery;	N/A
gingivectomy; gingivoplasty;	gingivectomy; gingivoplasty;	gingivectomy; gingivoplasty;	N/A
gingival troughing:	gingival troughing for crownimpressions;	gingival troughing;	N/A
crown lengthening;	soft tissue crown lengthening;	crown lengthening;	N/A
hemostasis of donor site;	hemostasis and coagulation;	hemostasis of donor site;	N/A
Proposed DeviceSIROLaser Advance+	Primary Predicate DeviceEpic 10(K121286)	Predicate DeviceSIROLaser Advance(K103753)	Predicate DeviceTHOR VR SingleDiode LaserTreatment Probe(K070024)
Surgical Indications for Use (continued)
removal of granulation tissue;		removal of granulation tissue;
laser assisted flap surgery;		laser assisted flap surgery;
debridement of diseasedepithelial lining;	incision and drainage of abscess;	debridement of diseasedepithelial lining;
incisions and draining ofabscesses;		incisions and draining ofabscesses;
tissue retraction forimpressions;	tissue retraction for impressions;	tissue retraction for impressions;
papillectomy; vestibuloplasty;	oral papillectomies; vestibuloplasty;	papillectomy; vestibuloplasty;
excision of lesions;		excision of lesions;
exposure of unerupted/partiallyerupted teeth;		exposure of unerupted/partiallyerupted teeth;
removal of hyperplastic tissues;	exposure of unerupted teeth;	removal of hyperplastic tissues;	N/A
treatment of aphthous ulcers;		treatment of aphthous ulcers;
leukoplakia;	leukoplakia;	leukoplakia;
pulpotomy; pulpotomy asadjunct to root canal therapy;	pulpotomy; pulpotomy as an adjunct toroot canal therapy;	pulpotomy; pulpotomy asadjunct to root canal therapy;
fibroma removal; gingivalincision and excision;	fibroma removal; gingival incision andexcision;	fibroma removal; gingivalincision and excision;
treatment of canker sores;herpetic ulcers of the oralmucosa;	treatment of canker sores, herpetic andaphthous ulcers of the oral mucosa;	treatment of canker sores;herpetic ulcers of the oralmucosa;
laser soft tissue curettage;	laser soft tissue curettage;	laser soft tissue curettage;
reduction of gingivalhypertrophy.	reduction of gingival hypertrophy.	reduction of gingivalhypertrophy.
Laser Periodontic Indications for Use
laser removal of diseased,infected, inflamed and necrosedsoft tissue; within theperiodontal pocket;	laser removal of diseased, infected,inflamed and necrosed soft tissue; withinthe periodontal pocket;	laser removal of diseased,infected, inflamed and necrosedsoft tissue; within theperiodontal pocket;
sulcular debridement (removalof diseased, infected, inflamedand necrosed soft tissue in theperiodontal pocket to improveclinical indices includinggingival index, gingivalbleeding index, probe depth,attachment loss and toothinability);	sulcular debridement (removal ofdiseased, infected, inflamed and necrosedsoft tissue in the periodontal pocket toimprove clinical indices includinggingival index, gingival bleeding index,probe depth, attachment loss and toothmobility);	sulcular debridement (removalof diseased, infected, inflamedand necrosed soft tissue in theperiodontal pocket to improveclinical indices includinggingival index, gingival bleedingindex, probe depth, attachmentloss and tooth inability);	N/A
Proposed DeviceSIROLaser Advance+	Primary Predicate DeviceEpic 10(K121286)	Predicate DeviceSIROLaser Advance(K103753)	Predicate DeviceTHOR VR SingleDiode LaserTreatment Probe(K070024)
Tooth Whitening
Light activation for bleachingmaterials for teeth whitening;	Light activation for bleaching materialsfor teeth whitening;	N/A	N/A
Laser-assistedwhitening/bleaching of teeth.	Laser-assisted whitening/bleaching ofteeth.
Low Level Laser Therapy
Intended to emit energy in thered and infrared spectrum toprovide topical heating for thepurpose of elevating tissuetemperature for the temporaryrelief of minor muscle and jointpain and stiffness, minorarthritis pain, or muscle spasm,and for the temporary increasein local blood circulationand/or temporary relaxation ofmuscles.	Topical heating for the purpose ofelevating tissue temperature for atemporary relief of minor muscle andjoint pain and stiffness, minor arthritispain, or muscle spasm, minor sprains,and minor back pain; the temporaryincrease in local blood circulation; thetemporary relaxation of muscle.	N/A	Intended to emitenergy in the infraredspectrum to providetopical heating for thepurpose of elevatingtissue temperature forthe temporary relief ofminor muscle and jointpain and stiffness,minor arthritis pain, ormuscle spasm, thetemporary increase inlocal blood circulationand/or temporaryrelaxation of muscles.

Table 6.1: Indications for Use

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Table 6.1 (continued): Indications for Use

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Table 6.1 (continued): Indications for Use

Table 6.2: Design

Proposed DeviceSIROLaser Advance+	Primary Predicate DeviceEpic 10(K121286)	Predicate DeviceSIROLaser Advance(K103753)	Predicate DeviceTHOR VR Single DiodeLaser Treatment Probe(K070024)
Laser Classification
970 nm Laser: Class IV	940 nm Laser: Class IV	970 nm Laser: Class IV	660 nm Laser: Class II
660 nm Laser: Class II
Laser Type
Solid state diode laser	Solid state diode laser	Solid state diode laser	Solid state diode laser
Laser Wavelength
970 nm (- 10 nm/+ 15 nm)	940 nm (+/- 10 nm)	970 nm (+/- 15 nm)	660 nm
660 nm (+/- 5 nm)
Proposed DeviceSIROLaser Advance+	Primary Predicate DeviceEpic 10(K121286)	Predicate DeviceSIROLaser Advance(K103753)	Predicate DeviceTHOR VR Single DiodeLaser Treatment Probe(K070024)
Optical Power
970 nm:0.2 W - 7.0 W (CW)14 W (peak optical power)660 nm:25 mW, 50 mW, 100 mW	10 W	7.0 W (max.) (CW)14 W (peak optical power)	30 mW, 75 mW, 200 mW
Emission Modalities
• Continuous Wave• Chopped (1 Hz - 10 kHz)• Peak Pulse (1.5 kHz - 20 kHz)	• Continuous Wave• Pulse Modulation (up to20 kHz)	• Continuous Wave• Chopped (1 Hz - 10 kHz)• Peak Pulse (up to 20 kHz).	• Continuous Wave
Pulse Duration
Chopped Mode:10 µsec. to 0.99 sec.Peak Pulse Mode: 23 µsec.	10 µsec. to 20 msec.	Chopped Mode:10 µsec. to 0.99 sec.Peak Pulse Mode: 23 µsec.	N/A
Aiming Beam Wavelength and Power
660 nm (+/- 5 nm)1 mW (max.)	625 nm to 670 nm1 mW (max.)	635 nm to 650 nm1mW (max.)	N/A
Optical Fiber Surgical Tips
Fiber Diameter:200 µm, 320 µm	Fiber Diameter:200 µm, 300 µm, 400 µm	Fiber Diameter:200 µm, 320 µm	N/A
• Single-use tips.• Integral laser fiber.• Plastic proximal connection hub.• Bendable stainless steel cannula.• Provided sterile (sterilized byethylene oxide).	• Single-use tips.• Integral laser fiber.• Plastic proximal connectionhub.• Bendable cannula.• Provided non-sterile.	• Single-use tips.• Laser fiber assembled with tip byuser.• Plastic proximal connection hub.• Bendable stainless steel cannula.• Provided non-sterile.	N/A
Laser Handpiece
• Handpiece connected by flexibleoptical fiber to control unit.• Finger switch laser activation.• Removable, sterilizable stainlesssteel outer sleeve.	• Handpiece connected byflexible optical fiber tocontrol unit.• Handpiece is sterilizable.	• Handpiece connected by flexibleoptical fiber to control unit.• Finger switch laser activation.• Removable, sterilizable outersleeve.	N/A
Laser Therapy Light Guides
Curved light guides;4 mm, 8mm diameter.	• Optional deep tissuehandpiece with adjustablespot-size spacer;• Optional whitening /contour handpiece.	N/A	• Single diode laser probe.• Diode laser cluster probe.
Activation Method
• Handpiece finger switch.• Optional wireless foot switch.	• Wireless footswitch.	• Handpiece finger switch.• Optional wireless foot switch.	• Probe activation finger switch.
Laser Control Unit Dimensions
182 mm x 197 mm x 189 mm	145 mm x 112 mm x 165 mm	182 mm x 197 mm x 189 mm	Unknown.
Laser Control Unit User Interface
Color touch screen graphical user interface.	Color touch screen graphical user interface.	Color touch screen graphical user interface.	Manual switches and buttons.

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Table 6.2 (continued): Design

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Table 6.2 (continued): Design

7. Non-Clinical Performance Data

The Testing to verify the performance requirements of the SIROLaser Advance+ was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.

Tests included in this premarket notification:

· Testing to verify the conformity of the proposed SIROLaser Advance+ with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
Testing to verify the conformity of the proposed SIROLaser Advance+ with the . requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
Testing to verify the conformity of the proposed SIROLaser Advance+ to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements).
Testing to verify the performance of the proposed SIROLaser Advance+ according to ● IEC 60601-2-22: (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
. Usability study conducted in conformity with IEC 62366 (Medical devices – Application of usability engineering to medical devices).
Biocompatibility assessment of patient contacting components of the proposed device . according to the requirements ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for cytotoxicity).
Validation of the device's software in conformity with IEC 62304 (Medical device software – Software lifecycle processes).

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Clinical Performance Data 8.

No human clinical data was included to support substantial equivalence.

9. Conclusion Regarding Substantial Equivalence

The information included in this premarket notification supports the substantial equivalence of the subject SIROLaser Advance+. The subject device has the identical intended use as the identified legally marketed predicate device. The subject device has the same intended use and incorporates the same technologies as the identified predicate devices.

Performance and biocompatibility data are included in this premarket notification to demonstrate the performance of the subject SIROLaser Advance+ against its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.

Regulation Number and Section

§ 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.