SIROLaser Advance+

K170500 · Dentsply Sirona · GEX · May 16, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170500
• Device Name: SIROLaser Advance+
• Applicant: Dentsply Sirona
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Solid-state diode laser system; generates 970 nm (infrared) and 660 nm (red) laser energy. Components: control unit with touchscreen GUI, laser handpiece, single-use 'EasyTip' fiber guides for surgery, and reusable 'MultiTip' light guides for therapy. Used in dental clinics by professionals. Surgical mode: fiber-guided incision, excision, hemostasis, coagulation, and vaporization of soft tissue. Whitening mode: light activation for bleaching agents. Low-level laser therapy mode: topical heating for pain relief and increased circulation. Output controlled via handpiece finger switch or optional wireless footswitch. Benefits: precise soft tissue management, reduced bleeding, and therapeutic pain relief.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), surgical laser performance (IEC 60601-2-22), usability (IEC 62366), biocompatibility (ISO 10993-5), and software validation (IEC 62304).

Technological Characteristics

Solid-state diode laser; 970 nm (Class IV) and 660 nm (Class II) wavelengths. Continuous, chopped (1 Hz-10 kHz), and peak pulse (1.5-20 kHz) emission modes. Touchscreen GUI. Single-use fiber tips (200/320 µm) and reusable light guides. Sterilization via ethylene oxide for tips; stainless steel handpiece sleeve is sterilizable. Connectivity: wireless footswitch option.

Indications for Use

Indicated for patients requiring intra- and extra-oral soft tissue surgery, teeth whitening, or low-level laser therapy for pain relief and muscle relaxation. Surgical applications include frenectomy, gingivectomy, biopsy, and periodontal pocket debridement. Whitening application involves light activation for bleaching materials. Low-level laser therapy provides topical heating for minor muscle/joint pain, arthritis, and muscle spasms.

Regulatory Classification

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.

Predicate Devices

• Epic 10 (K121286)
• SIROLaser Advance (K103753)
• THOR VR Single Diode Laser Treatment Probe (K070024)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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) | |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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:

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.

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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 Device<br>SIROLaser Advance+ | Primary Predicate Device<br>Epic 10<br>(K121286) | Predicate Device<br>SIROLaser Advance<br>(K103753) | Predicate Device<br>THOR VR Single<br>Diode Laser<br>Treatment Probe<br>(K070024) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surgical indications for Use: | | | |
| Intended for intra- and extra-<br>oral surgery including incision,<br>excision, hemostasis,<br>coagulation and vaporization of<br>soft tissue including marginal<br>and inter-dental and epithelial<br>lining of free gingiva and is<br>indicated for: | Incision, excision, vaporization, ablation<br>and coagulation of oral tissues including<br>marginal and inter-dental gingiva and<br>epithelial lining of free gingiva and the<br>following specific indications: | Intended for intra- and extra-oral<br>surgery including incision,<br>excision, hemostasis, coagulation<br>and vaporization of soft tissue<br>including marginal and inter-<br>dental and epithelial lining of free<br>gingiva and is indicated for: | N/A |
| frenectomy; frenotomy; | frenectomy; frenotomy | frenectomy; frenotomy; | N/A |
| biopsy; operculectomy; | excisional and incisional biopsies;<br>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<br>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<br>SIROLaser Advance+ | Primary Predicate Device<br>Epic 10<br>(K121286) | Predicate Device<br>SIROLaser Advance<br>(K103753) | Predicate Device<br>THOR VR Single<br>Diode Laser<br>Treatment Probe<br>(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<br>epithelial lining; | incision and drainage of abscess; | debridement of diseased<br>epithelial lining; | |
| incisions and draining of<br>abscesses; | | incisions and draining of<br>abscesses; | |
| tissue retraction for<br>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<br>erupted teeth; | | exposure of unerupted/partially<br>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<br>adjunct to root canal therapy; | pulpotomy; pulpotomy as an adjunct to<br>root canal therapy; | pulpotomy; pulpotomy as<br>adjunct to root canal therapy; | |
| fibroma removal; gingival<br>incision and excision; | fibroma removal; gingival incision and<br>excision; | fibroma removal; gingival<br>incision and excision; | |
| treatment of canker sores;<br>herpetic ulcers of the oral<br>mucosa; | treatment of canker sores, herpetic and<br>aphthous ulcers of the oral mucosa; | treatment of canker sores;<br>herpetic ulcers of the oral<br>mucosa; | |
| laser soft tissue curettage; | laser soft tissue curettage; | laser soft tissue curettage; | |
| reduction of gingival<br>hypertrophy. | reduction of gingival hypertrophy. | reduction of gingival<br>hypertrophy. | |
| Laser Periodontic Indications for Use | | | |
| laser removal of diseased,<br>infected, inflamed and necrosed<br>soft tissue; within the<br>periodontal pocket; | laser removal of diseased, infected,<br>inflamed and necrosed soft tissue; within<br>the periodontal pocket; | laser removal of diseased,<br>infected, inflamed and necrosed<br>soft tissue; within the<br>periodontal pocket; | |
| sulcular debridement (removal<br>of diseased, infected, inflamed<br>and necrosed soft tissue in the<br>periodontal pocket to improve<br>clinical indices including<br>gingival index, gingival<br>bleeding index, probe depth,<br>attachment loss and tooth<br>inability); | sulcular debridement (removal of<br>diseased, infected, inflamed and necrosed<br>soft tissue in the periodontal pocket to<br>improve clinical indices including<br>gingival index, gingival bleeding index,<br>probe depth, attachment loss and tooth<br>mobility); | sulcular debridement (removal<br>of diseased, infected, inflamed<br>and necrosed soft tissue in the<br>periodontal pocket to improve<br>clinical indices including<br>gingival index, gingival bleeding<br>index, probe depth, attachment<br>loss and tooth inability); | N/A |
| Proposed Device<br>SIROLaser Advance+ | Primary Predicate Device<br>Epic 10<br>(K121286) | Predicate Device<br>SIROLaser Advance<br>(K103753) | Predicate Device<br>THOR VR Single<br>Diode Laser<br>Treatment Probe<br>(K070024) |
| Tooth Whitening | | | |
| Light activation for bleaching<br>materials for teeth whitening; | Light activation for bleaching materials<br>for teeth whitening; | N/A | N/A |
| Laser-assisted<br>whitening/bleaching of teeth. | Laser-assisted whitening/bleaching of<br>teeth. | | |
| Low Level Laser Therapy | | | |
| Intended to emit energy in the<br>red and infrared spectrum to<br>provide topical heating for the<br>purpose of elevating tissue<br>temperature for the temporary<br>relief of minor muscle and joint<br>pain and stiffness, minor<br>arthritis pain, or muscle spasm,<br>and for the temporary increase<br>in local blood circulation<br>and/or temporary relaxation of<br>muscles. | Topical heating for the purpose of<br>elevating tissue temperature for a<br>temporary relief of minor muscle and<br>joint pain and stiffness, minor arthritis<br>pain, or muscle spasm, minor sprains,<br>and minor back pain; the temporary<br>increase in local blood circulation; the<br>temporary relaxation of muscle. | N/A | Intended to emit<br>energy in the infrared<br>spectrum to provide<br>topical heating for the<br>purpose of elevating<br>tissue temperature for<br>the temporary relief of<br>minor muscle and joint<br>pain and stiffness,<br>minor arthritis pain, or<br>muscle spasm, the<br>temporary increase in<br>local blood circulation<br>and/or temporary<br>relaxation 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 Device<br>SIROLaser Advance+ | Primary Predicate Device<br>Epic 10<br>(K121286) | Predicate Device<br>SIROLaser Advance<br>(K103753) | Predicate Device<br>THOR VR Single Diode<br>Laser Treatment Probe<br>(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<br>SIROLaser Advance+ | Primary Predicate Device<br>Epic 10<br>(K121286) | Predicate Device<br>SIROLaser Advance<br>(K103753) | Predicate Device<br>THOR VR Single Diode<br>Laser Treatment Probe<br>(K070024) |
| Optical Power | | | |
| 970 nm:<br>0.2 W - 7.0 W (CW)<br>14 W (peak optical power)<br>660 nm:<br>25 mW, 50 mW, 100 mW | 10 W | 7.0 W (max.) (CW)<br>14 W (peak optical power) | 30 mW, 75 mW, 200 mW |
| Emission Modalities | | | |
| • Continuous Wave<br>• Chopped (1 Hz - 10 kHz)<br>• Peak Pulse (1.5 kHz - 20 kHz) | • Continuous Wave<br>• Pulse Modulation (up to<br>20 kHz) | • Continuous Wave<br>• Chopped (1 Hz - 10 kHz)<br>• Peak Pulse (up to 20 kHz). | • Continuous Wave |
| Pulse Duration | | | |
| Chopped Mode:<br>10 µsec. to 0.99 sec.<br>Peak Pulse Mode: 23 µsec. | 10 µsec. to 20 msec. | Chopped Mode:<br>10 µsec. to 0.99 sec.<br>Peak Pulse Mode: 23 µsec. | N/A |
| Aiming Beam Wavelength and Power | | | |
| 660 nm (+/- 5 nm)<br>1 mW (max.) | 625 nm to 670 nm<br>1 mW (max.) | 635 nm to 650 nm<br>1mW (max.) | N/A |
| Optical Fiber Surgical Tips | | | |
| Fiber Diameter:<br>200 µm, 320 µm | Fiber Diameter:<br>200 µm, 300 µm, 400 µm | Fiber Diameter:<br>200 µm, 320 µm | N/A |
| • Single-use tips.<br>• Integral laser fiber.<br>• Plastic proximal connection hub.<br>• Bendable stainless steel cannula.<br>• Provided sterile (sterilized by<br>ethylene oxide). | • Single-use tips.<br>• Integral laser fiber.<br>• Plastic proximal connection<br>hub.<br>• Bendable cannula.<br>• Provided non-sterile. | • Single-use tips.<br>• Laser fiber assembled with tip by<br>user.<br>• Plastic proximal connection hub.<br>• Bendable stainless steel cannula.<br>• Provided non-sterile. | N/A |
| Laser Handpiece | | | |
| • Handpiece connected by flexible<br>optical fiber to control unit.<br>• Finger switch laser activation.<br>• Removable, sterilizable stainless<br>steel outer sleeve. | • Handpiece connected by<br>flexible optical fiber to<br>control unit.<br>• Handpiece is sterilizable. | • Handpiece connected by flexible<br>optical fiber to control unit.<br>• Finger switch laser activation.<br>• Removable, sterilizable outer<br>sleeve. | N/A |
| Laser Therapy Light Guides | | | |
| Curved light guides;<br>4 mm, 8mm diameter. | • Optional deep tissue<br>handpiece with adjustable<br>spot-size spacer;<br>• Optional whitening /<br>contour handpiece. | N/A | • S…