SAPPHIRE ST PORTABLE DIODE LASER

K103667 · Den-Mat Holdings, LLC · GEX · Dec 29, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K103667
• Device Name: SAPPHIRE ST PORTABLE DIODE LASER
• Applicant: Den-Mat Holdings, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

Device Story

Sapphire ST Portable Diode Laser is a Class 4 surgical laser for dental soft tissue procedures. Device consists of a control module with microprocessor, user interface, and power supply; a corded handpiece housing 808 nm diode laser and aiming beam; and disposable 400 μm fiberoptic tips. Operated by trained clinicians in dental settings. Clinician selects continuous wave or pulsed mode via membrane touch pad; laser energy delivered through fiberoptic tip to target tissue. Device provides hemostasis, incision, and ablation capabilities; also used for light-activated teeth whitening. Microprocessor controls laser output and monitors status. Benefits include precise soft tissue management and reduced bleeding. Output accuracy verified against international standards (IEC 60601-2-22).

Clinical Evidence

Bench testing only. Comparative performance testing measured working beam output accuracy in Continuous Wave and Pulse modes. Subject device output variance was 1.4% (CW) and 0.5% (P), compared to predicate variance of 2.2% (CW) and 2.7% (P). Both devices satisfied the IEC 60601-2-22 requirement that output vary by less than ±20% of the setting.

Technological Characteristics

808 nm (±5 nm) solid-state diode laser; 0.1–3.0 W (CW) and 0.1–5.0 W (Pulse) output; 640 nm aiming beam. Convection cooled. Powered by 15W, 5 VDC lithium-ion battery or AC/DC supply. User interface: membrane touch pad, LCD, LED indicators. Disposable 400 μm fiberoptic tips. Complies with IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.

Indications for Use

Indicated for dental intraoral soft tissue, oral maxilla-facial, and cosmetic surgery in patients requiring ablation, incision, excision, vaporization, or coagulation of soft tissue. Specific procedures include biopsies, hemostasis, apthous ulcer treatment, frenectomy/frenotomy, gingival procedures, abscess drainage, operculectomy, papillectomy, fibroma removal, crown lengthening, sulcular debridement, tissue retraction, and laser-assisted teeth whitening.

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

• Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser (K062258)
• Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K081214)
• Ivoclar Vivadent, Inc. Odyssey 2.4G (K050453)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

## Den-Mat Holding's Sapphire ST Portable Diode Laser

| Submitted for: | Den-Mat Holdings, LLC |
|-----------------------------|------------------------------------|
| | 2727 Skyway Drive |
| | Santa Maria, CA 93455 |
| Phone: | 805-922-8491 |
| Facsimile: | 805-347-7940 |
| Contact Person: | Alan B. Matthews, ext. 2927 |
| Date Prepared: | 11 November 2010 |
| Device Proprietary Name(s): | Sapphire ST Portable Diode Laser |
| Common or Usual Name: | 808 nm Diode Laser (Class 4 laser) |
| Product Classification: | Laser instrument, surgical |
| Product Code: | GEX |

Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser (K062258); Zap Lasers, LLC Styla MicroLaser/StylaOrtho Laser (K081214); Ivoclar Vivadent, Inc. Odyssey 2.4G (K050453)

## Rationale for Substantial Equivalence

Predicate Device(s):

Both the subject and predicate laser devices share similar intended uses and indications for use, technical characteristics, features, and specifications. The laser characteristics of the Sapphire ST Portable Diode Laser, including working and aiming beam wavelengths and outputs, laser delivery methods, safety features, and performance specifications are similar to those of the cleared Odyssey Navigator, Odyssey 2.4G, and Styla MicroLaser Diode Lasers. The laser operating system and controls of the subject device are similar to those used by the previously-cleared predicate devices that have proven safety and effectiveness records in the treatment of the claimed indications. Safety and performance test results have been shown to satisfy applicable international standards recognized by the Agency.

#### Intended Uses and Indications for Use

The Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for

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impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

## Device Description

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The Sapphire ST Portable Diode Laser is comprised of three basic parts: the control box ("control module") with microprocessor and user interface for selection of mode (continuous wave or pulsed) and laser output to provide visual indications of power settings and of the unit's status, and features the unit's power ON/OFF switch, footswitch jack and key switch; the second component is the corded laser handpiece that houses the laser working beam and aiming beam diodes and control board, optics and harat sink, on/off switch, and the disposable fiberoptic tip assembly. An optional footswitch is available that plugs into the control module and can be used to activate the laser working beam instead of the handpiece on/off actuator. Electrical power is taken from the AC/DC Power Supply that plugs into a standard electrical outlet and charges a 15W, 5 VDC lithium-ion battery that generates 4 amps used to drive the diode laser.

## Conformity to International Standards

The Sapphire ST Portable Diode Laser complies with the performance requirements listed in 21 CFR 1040.10 and 1040.11, with permissible deviations pursuant to laser Notice 50, dated July 26, 2001. Additionally, the subject device has been shown to conform to the same international electrical safety standards for electrical medical devices in general, and lasers in particular, as the predicate devices: IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.

## Comparative Performance Data

The Sapphire ST Portable Diode Laser has been tested side-by-side against one of the predicate devices. Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings by an average of only 1.4% in CW and 0.5% in P compared to the predicate's variance of 2.2% in CW and 2.7% in P. The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device's setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard, with the subject device demonstrating less variability (more control) than the cleared predicate device.

# Comparison of Features and Characteristics

Table 1, following, lists key Features and Characteristics of the subject and three predicate devices.

Table 1.

| Den-Mat Holdings,<br>LLC Sapphire ST<br>Portable Diode | Ivoclar Vivadent,<br>Inc. Odyssey<br>Navigator Diode | Zap Lasers, Inc.<br>Styla MicroLaser<br>Diode Laser | Ivoclar Vivadent,<br>Inc Odyssey 2.4G<br>Diode Laser |
|--------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------|
|--------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------|

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| | Laser | | Laser | |
|-----------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------|-------------------------------------------------|
| Wavelength | $808 \pm 5$ nm | $810 \pm 20$ nm | $808 \pm 5$ nm | $810 \pm 20$ nm |
| Power | 0.1 – 3.0 W (CW) &<br>0.1 – 5.0 W (Pulse) | 0.1 – 3.0 W (CW &<br>Pulse) | 2.0 W maximum | 0.1 – 5.0 W (CW &<br>Pulse) |
| Aiming Beam | 640 nm ( $\pm 10$ nm),<br>maximum 2mW<br>(adjustable) | 630 – 650 nm,<br>maximum 2 mW<br>(adjustable) | 650 nm, maximum<br>5 mW (adjustable) | 630 – 650 nm,<br>maximum 2 mW<br>(adjustable) |
| Cooling System | Convection cooled | Fan air cooled | Convection cooled | Fan air cooled |
| Pulse Control | Digital emission<br>control | Digital emission<br>control | Digital emission<br>control | Digital emission<br>control |
| Laser Source | Solid-state diode | Solid-state diode | Solid-state diode | Solid-state diode |
| Power<br>Requirements | 24W 5VDC<br>supplied from 110 –<br>120 VAC @ 60 Hz<br>or 220 – 240 VAC<br>@ 50 Hz<br>(switchable) | 100-240 VAC @<br>50-60 Hz, 0.5A<br>(switchable) | 100-240VAC @ 50-<br>60 Hz, 0.8A max<br>(switchable) | 100-240 VAC @<br>50-60 Hz, 1.5A<br>(switchable) |
| User<br>Interface | Membrane touch<br>pad, LCD Display,<br>LED Indicators | LCD Touch Screen | Membrane touch<br>pads, LED Display | Membrane touch<br>pads, LCD display |
| Fiberoptic<br>Tip | Disposable, 400 μm<br>unit dose | Disposable, 400 μm<br>unit dose | Disposable, 400 μm<br>unit dose | 6 meter fiber<br>cartridge, 400 μm<br>diameter |
| 510(k)<br>Number | Pending this<br>application | K062258 | K081214 | K050453 |

#### Conclusion

The subject device shares the same principle of operation as the three predicate devices. All arc diode lasers that emit radiant energy at approximately 808 nm with outputs that range from 0.1 to 5.0W. All deliver collimated laser energy to subject target tissue via 400 um fiberoptic tips controlled by trained, experienced clinicians. All share the same indications for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. All have been found to satisfy international safety standards relating to electrical medical devices in general and medical lasers in particular. All share the similar safety labeling, device interlocks, and associated safety features. Both the subject and a predicate device's output were measured and compared to their settings to determine the accuracy of the devices' controls. Both met international standards pertaining to accuracy of output of the working beam, but the difference between the subject device's output and its setting was much less than the predicate's, demonstrating not only conformance to the standard, but also superior control over laser emissions.

The Sapphire ST Portable Diode Laser device shares intended uses, principle of operation, technical attributes, functional capabilities, and performance characteristics with the listed predicate devices. Both the subject and predicate devices have been shown to comply with applicable Federal and international safety and performance standards. The Sapphire ST Portable Laser is substantially equivalent to the listed predicate laser surgical devices and does not raise any issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUM" is arranged vertically along the left side of the logo.

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

Den-Mat Holdings, LLC % Regulatory Technology Services, LLC Mr. Mark Job 1394 2511 Street. NW Buffalo, Minnesota 55313

DEC 2 9 2010

Re: K103667

Trade/Device Name: Sapphire ST Portable Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 14, 2010 Received: December 15, 2010

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FOR Dothan DR

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number (if known):_k|0 2 6 6 7

Device Name: Sapphire ST Portable Diode Laser

Indications for Use:

The Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiberoptic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectorny; frenotomy, gingival incision and excision; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

P. Antonio

(Division Sign-C. T) (Division Sign-C-1, Orthopedic, Division of on of evices

510(k) Number .

DEC 2 9 2010