(84 days)
Not Found
No
The document describes a laser device with adjustable settings and preset modes, controlled by software. There is no mention of AI, ML, image processing, or any learning capabilities. The testing focuses on safety, performance standards, usability, biocompatibility, and software validation, none of which indicate the presence of AI/ML.
Yes
The device is described as "therapeutic" in the "Summary of Performance Studies" section ("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)"). Additionally, the "Intended Use / Indications for Use" section lists "Low Level Laser Therapy" as an indication, which involves therapeutic applications like pain relief and increased blood circulation.
No
The device is described for surgical, therapeutic, and whitening applications, but not for diagnostic purposes. Its performance testing specifically mentions IEC 60601-2-22, which covers "surgical, cosmetic, therapeutic, and diagnostic laser equipment," but the list of its intended uses does not include any diagnostic functions.
No
The device description clearly states it consists of hardware components including a laser control unit, laser handpiece, and fiber guides, in addition to software.
Based on the provided information, the SIROLaser Advance+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes surgical procedures, teeth whitening, and low-level laser therapy performed directly on the patient's body (intra- and extra-oral tissues, teeth, muscles, joints). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a laser system designed to deliver energy to the patient's tissues. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the SIROLaser Advance+ is a therapeutic and surgical laser device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intra- and extra-oral soft tissue, teeth, muscle, and joints.
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)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
Indications for Use
510(k) Number (if known) к170500
Device Name: SIROLaser Advance+
Indications for Use (Describe)
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.
| 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 |
4
4. Description of Device:
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.
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.
5
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 Device
SIROLaser Advance+ | Primary Predicate Device
Epic 10
(K121286) | Predicate Device
SIROLaser Advance
(K103753) | Predicate Device
THOR VR Single
Diode Laser
Treatment Probe
(K070024) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surgical indications for Use: | | | |
| 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: | Incision, excision, vaporization, ablation
and coagulation of oral tissues including
marginal and inter-dental gingiva and
epithelial lining of free gingiva and the
following specific indications: | 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: | 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 crown
impressions; | 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 Device
SIROLaser Advance+ | Primary Predicate Device
Epic 10
(K121286) | Predicate Device
SIROLaser Advance
(K103753) | Predicate Device
THOR VR Single
Diode Laser
Treatment 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 diseased
epithelial lining; | incision and drainage of abscess; | debridement of diseased
epithelial lining; | |
| incisions and draining of
abscesses; | | incisions and draining of
abscesses; | |
| tissue retraction for
impressions; | tissue retraction for impressions; | tissue retraction for impressions; | |
| papillectomy; vestibuloplasty; | oral papillectomies; vestibuloplasty; | papillectomy; vestibuloplasty; | |
| excision of lesions; | | excision of lesions; | |
| exposure of unerupted/partially
erupted teeth; | | exposure of unerupted/partially
erupted 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 as
adjunct to root canal therapy; | pulpotomy; pulpotomy as an adjunct to
root canal therapy; | pulpotomy; pulpotomy as
adjunct to root canal therapy; | |
| fibroma removal; gingival
incision and excision; | fibroma removal; gingival incision and
excision; | fibroma removal; gingival
incision and excision; | |
| treatment of canker sores;
herpetic ulcers of the oral
mucosa; | treatment of canker sores, herpetic and
aphthous ulcers of the oral mucosa; | treatment of canker sores;
herpetic ulcers of the oral
mucosa; | |
| laser soft tissue curettage; | laser soft tissue curettage; | laser soft tissue curettage; | |
| reduction of gingival
hypertrophy. | reduction of gingival hypertrophy. | reduction of gingival
hypertrophy. | |
| Laser Periodontic Indications for Use | | | |
| laser removal of diseased,
infected, inflamed and necrosed
soft tissue; within the
periodontal pocket; | laser removal of diseased, infected,
inflamed and necrosed soft tissue; within
the periodontal pocket; | 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); | 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
mobility); | 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); | N/A |
| Proposed Device
SIROLaser Advance+ | Primary Predicate Device
Epic 10
(K121286) | Predicate Device
SIROLaser Advance
(K103753) | Predicate Device
THOR VR Single
Diode Laser
Treatment Probe
(K070024) |
| Tooth Whitening | | | |
| Light activation for bleaching
materials for teeth whitening; | Light activation for bleaching materials
for teeth whitening; | N/A | N/A |
| Laser-assisted
whitening/bleaching of teeth. | Laser-assisted whitening/bleaching of
teeth. | | |
| Low Level Laser Therapy | | | |
| 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. | Topical heating for the purpose of
elevating tissue temperature for a
temporary relief of minor muscle and
joint pain and stiffness, minor arthritis
pain, or muscle spasm, minor sprains,
and minor back pain; the temporary
increase in local blood circulation; the
temporary relaxation of muscle. | N/A | Intended to emit
energy in the 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, the
temporary increase in
local blood circulation
and/or temporary
relaxation of muscles. |
Table 6.1: Indications for Use
6
Table 6.1 (continued): Indications for Use
7
Table 6.1 (continued): Indications for Use
Table 6.2: Design
| Proposed Device
SIROLaser Advance+ | Primary Predicate Device
Epic 10
(K121286) | Predicate Device
SIROLaser Advance
(K103753) | Predicate Device
THOR VR Single Diode
Laser 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 Device
SIROLaser Advance+ | Primary Predicate Device
Epic 10
(K121286) | Predicate Device
SIROLaser Advance
(K103753) | Predicate Device
THOR VR Single Diode
Laser 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 to
20 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 nm
1 mW (max.) | 635 nm to 650 nm
1mW (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 by
ethylene oxide). | • Single-use tips.
• Integral laser fiber.
• Plastic proximal connection
hub.
• Bendable cannula.
• Provided non-sterile. | • Single-use tips.
• Laser fiber assembled with tip by
user.
• Plastic proximal connection hub.
• Bendable stainless steel cannula.
• Provided non-sterile. | N/A |
| Laser Handpiece | | | |
| • Handpiece connected by flexible
optical fiber to control unit.
• Finger switch laser activation.
• Removable, sterilizable stainless
steel outer sleeve. | • Handpiece connected by
flexible optical fiber to
control unit.
• Handpiece is sterilizable. | • Handpiece connected by flexible
optical fiber to control unit.
• Finger switch laser activation.
• Removable, sterilizable outer
sleeve. | N/A |
| Laser Therapy Light Guides | | | |
| Curved light guides;
4 mm, 8mm diameter. | • Optional deep tissue
handpiece with adjustable
spot-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. |
8
Table 6.2 (continued): Design
9
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.