SPPHINE PLUS STM 3W DIODE LASER
Device Facts
| Record ID | K110079 |
|---|---|
| Device Name | SPPHINE PLUS STM 3W DIODE LASER |
| Applicant | Den-Mat Holdings, LLC |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Feb 10, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for Use
The Sapphire Plus STM 3W 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 fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision; 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; and vestibuloplasty.
Device Story
Sapphire Plus STM 3W Diode Laser is a plug-in module for the Sapphire Plus Light Source Unit; operates as a Class 4 surgical laser. Input: low-voltage DC current from the base unit. Transformation: microprocessor-controlled diode laser generates 808nm working beam and 640nm aiming beam. Output: laser energy delivered via disposable 400μm silica fiberoptic tip. Used in dental clinics by trained clinicians. Control module allows selection of continuous wave or pulsed modes, power settings, and status monitoring. Footswitch or handpiece switch activates laser. Clinical benefit: soft tissue surgery with reduced pain and faster recovery compared to traditional methods. Output affects clinical decision-making by enabling precise tissue ablation, incision, and coagulation.
Clinical Evidence
Bench testing only. Side-by-side comparative performance testing against a predicate device measured output accuracy in Continuous Wave and Pulse modes. Subject device demonstrated 1.4% variance in CW and 0.5% in Pulse mode, compared to 2.2% and 2.7% for the predicate, both well within the ±20% limit required by IEC 60601-2-22. Literature review provided to support safety and effectiveness of 808nm diode lasers for indicated soft tissue procedures.
Technological Characteristics
808nm (±5nm) GaAlAs diode laser; 640nm (±10nm) aiming beam. Output 0.1-3.0W. Convection cooled. 400μm disposable silica fiberoptic tip. Powered by 15W, 5VDC rechargeable lithium-ion battery. Microprocessor-controlled interface with membrane touch pad, LCD, and LED indicators. Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-22, 60825-1, and 21 CFR 1040.10/11.
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 tissues. Specific procedures include biopsies, hemostasis, aphthous ulcer treatment, frenectomy, frenotomy, gingivectomy, gingivoplasty, abscess drainage, operculectomy, papillectomy, fibroma removal, crown lengthening, sulcular debridement, and tissue retraction.
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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Image /page/0/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address of the company is listed as 2727 Skyway Drive, Santa Maria, CA 93455.
K110079
FEB - 10 2011
# 510(k) Summary of Safety and Effectiveness
## Den-Mat Holding's Sapphire Plus STM 3W Diode Laser
| Submitted for: | Den-Mat Holdings, LLC<br>2727 Skyway Drive<br>Santa Maria, CA 93455 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 805-922-8491 |
| Facsimile: | 805-347-7940 |
| Contact Person: | Alan B. Matthews, ext. 2927 |
| Date Prepared: | 7 December 2010 |
| Device Proprietary Name(s): | Sapphire Plus STM 3W Diode Laser |
| Common or Usual Name: | 808 nm Diode Laser (Class 4 laser) |
| Product Classification: | Laser instrument, surgical |
| Product Code: | GEX |
| Predicate Device(s): | Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser<br>(K062258); Zap Lasers, LLC Styla MicroLaser/StylaOrtho<br>Laser (K081214); Ivoclar Vivadent, Inc. Odyssey 2.4G<br>(K050453) |
## Rationale for Substantial Equivalence
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 Plus STM 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 Plus STM 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;
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soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.
## Device Description
The Sapphire Plus STM Laser is a plug-in option for the Sapphire Plus Light Source Unit. The Sapphire Plus Light Source Unit contains a xenon arc lamp that, depending on which handpiece is attached, has been cleared for use as either a Curing/Whitening attachment (K081287) or as an adjunct for visual oral tissue examination (K073483). In both cases, these two attachments use different portions of the broad-spectrum xenon arc light's emissions to perform their clinical functions.
Like the other two attachments for the Sapphire Plus Light, the Sapphire Plus STM Laser also plugs into the Sapphire Plus Light. Unlike the other two attachments, however, when the Sapphire Plus STM Diode Laser is attached to the Sapphire Plus Light, only low-voltage DC current -not visible light -- is sent to the Laser. The Sapphire Plus STM Diode Laser is comprised of two basic parts: the control box ("control module") with microprocessor and user interface, and the Laser Handpiece containing the working and aiming beam laser diodes and the laser ON/OFF switch. The Control Module interface allows selection of mode (continuous wave or pulsed) and laser output, provides visual indications of power settings and of the unit's status, and features the unit's footswitch jack and operating key switch and the Emergency STOP button. The Laser Handpiece is found at the end of a six foot long power/communications cord that is plugged into the Control Module's light guide port. The Handpiece houses the 808 ± 5nm laser working beam diode and the 640 ± 10nm aiming beam diode and control board, optics and heat 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. The Sapphire Plus STM Laser is powered by a 15W, 5 VDC rechargeable lithium-ion battery that receives its energy from the Sapphire Plus Light Source Unit.
## Conformity to International Standards
The Sapphire Plus STM 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, including electrical safety and electromagnetic compatibility and resistance to interference (EMC and EMI): IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.
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Image /page/2/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address '2727 Skyway Drive, Santa Maria, CA 03455' is printed to the right of the logo.
## NON-CLINICAL COMPARISONS Comparative Performance Data
The Sapphire Plus STM 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.
The Table "Comparison of Lasing Characteristics" immediately following and Table 1 Key Features and Characteristics provide tabular comparisons of the subject device technical and operational characteristics to those of the predicate devices.
| Comparison of Lasing Characteristics | | | | |
|------------------------------------------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|
| Device<br>Description: | Sapphire Plus<br>STM | Odyssey<br>Navigator | Styla<br>MicroLaser | Odyssey 2.4G |
| Output range, CW | 0.1 - 3.0W | 0.1 - 3.0W | 2W maximum | 0.1 - 5.0 W |
| Increments<br>available | 0.1W | 0.1W | unknown | 0.1W |
| Energy available<br>(per 1 second<br>emission, CW) | 3J | 3J | 2J | 5J |
| Output range, P | 0.1 - 3.0W | 0.1 - 3.0 W | 0.1 - 2.0 W | 0.1 - 5.0W |
| Increments<br>available | 0.1W | 0.1W | 0.1W | 0.1W |
| Method for pulsing | Digital emission control | Digital emission<br>control | Digital emission<br>control | Digital emission<br>control |
| Frequency of pulse | 4 Hz | 10 Hz | 10 Hz | 1 Hz |
| Pulse train<br>duration | 0.125 seconds | 0.05 seconds | 0.05 seconds | 0.5 seconds |
| Duty cycle | 50% | 50% | 50% | 50% |
| Energy available<br>(per 1 second<br>emission, CW @<br>maximum output) | 3.0J | 3.0J | 2.0J | 5.0J |
| Fiberoptic tip<br>diameter | 400 μm | 400 μm | 400 μm | 400 μm |
| Beam diameter | 150 μm | unknown | unknown | unknown |
| Working Beam<br>Wavelength (nm) | 808 nm (±5nm) | 810 (±20 nm) | 808 (±5 nm) | 810 nm (±20 nm) |
| Light source | Single emitter solid state<br>diode | Single emitter solid<br>state diode | Single emitter solid<br>state diode | Single-emitter solid<br>state diode |
| Beam divergence<br>angle | 9° (± 1°) | 9° (±1°) | unknown | 9° (±1°) |
| Aiming beam<br>present? | Yes | Yes | Yes | Yes |
| If present,<br>wavelength | 640 nm (±10nm) | 630 - 650 nm | 650 nm | 630 - 660nm (±<br>15nm) |
| Output | 2mW | 2 mW | 5 mW | 2mW |
| Adjustable? | Yes, from 0 mW<br>(OFF) to 2 mW | Yes, from 0 mW<br>(OFF) to 2mW | Yes | Yes, from 0 mW<br>(OFF) to 2 mW |
| Laser medium | GaAIAs Laser Diode | GaAIAs Laser<br>Diode | GaAIAs Laser<br>Diode | GaAIAs Laser<br>Diode |
| Cooling method | Convection | Convection | Convection | Air cooled fan |
| Aperture stop<br>present? | Yes | Unknown | Unknown | Unknown |
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Image /page/3/Picture/0 description: The image shows a logo for DenMat. The logo consists of the letters 'dm' in a stylized font, with the 'd' and 'm' connected at the top. Below the letters 'dm' is the word 'DenMat' in a smaller, sans-serif font. The logo is black and white.
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Image /page/4/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo includes the letters 'dm' stacked on top of the word 'DenMat'. To the right of the logo is the text 'DEN-MAT HOLDINGS, LLC' followed by the address '2727 SKYWAY DRIVE, SANTA MARIA, CA 93455'.
## Comparison of Features and Characteristics
Table 1, following, lists key Features and Characteristics of the subject and three predicate devices.
| œ | | | |
|---|---|---|-----|
| 4 | 1 | C | L B |
| | Den-Mat Holdings,<br>LLC Sapphire Plus<br>STM laser | Ivoclar Vivadent,<br>Inc. Odyssey<br>Navigator Diode<br>Laser | Zap Lasers, Inc.<br>Styla MicroLaser<br>Diode Laser | Ivoclar Vivadent,<br>Inc Odyssey 2.4G<br>Diode Laser |
|-----------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------------------------------------|
| Wavelength | 808 ±5 nm | 810 ±20 nm | 808 ±5 nm | 810 ±20 nm |
| Power | 0.1 – 3.0 W (CW) &<br>(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 (±10 nm),<br>maximum 2 mW<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<br>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 | 15W 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<br>6 meter fiber<br>cartridge, 400 μm<br>diameter |
| Fiberoptic<br>Tip | Disposable, 400 μm<br>unit dose | Disposable, 400 μm<br>unit dose | Disposable, 400 μm<br>unit dose | Disposable, 400 μm<br>unit dose |
| 510(k)<br>Number | Pending this<br>application | K062258 | K081214 | K050453 |
# Studies from the Literature Showing Safety and Effectiveness of 808 nm Diode Lasers Used in Dental Intraoral Soft Tissue General, Oral Maxilla-facial and Cosmetic Surgery
The literature abounds with studies that describe the safe and effective uses for 810 nm diode lasers for soft tissue indications. This application includes references to articles that describe the use and effectiveness of soft tissue diode lasers in intra-oral applications of the type intended for the Sapphire Plus STM 3W Diode Laser and describes how the Sapphire Plus STM Diode Laser is equivalent to these devices. Included in the Section "Clinical Reviews Related to the Sapphire Plus 3W Diode Laser" are references to meta-reviews, clinical studies, in vitro studies, and animal studies. The studies point to the 808 nm diode laser's affinity for hemoglobin and melanin and describe how this is particularly effective in soft tissue treatments and point to the
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Image /page/5/Picture/0 description: The image shows the logo for Den-Mat Holdings, LLC. The logo consists of the letters 'dm' in a stylized font, with the word 'DenMat' written below. The address '2727 Skyway Drive, Santa Maria, CA 93455' is printed to the right of the logo.
device's ability to achieve clinical objectives that are overall less painful and exhibit quicker recovery times than traditional surgical means. The studies support the contention that diode lasers that emit in this approximate wavelength are similarly effective and safe.
#### Conclusion
The subject device shares the same principle of operation as the three predicate devices, All are 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 silica optical fibers controlled by trained, experienced clinicians. All offer visible aiming beams that are adjustable and that may be turned off. 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 subject and the predicate devices share similar features and characteristics, from working beam lasing characteristics to control interfaces and status indicators. Laser energy for all devices is transferred to patient tissues via 400 um silica optical fibers.
The Sapphire Plus STM Diode Laser 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 Plus STM Laser performs it's surgical function using the same technological means as similar dental soft-tissue lasers whose safety and effectiveness has been reported in the literature. The Sapphire Plus STM Diode Laser is substantially equivalent to the listed predicate laser surgical devices and does not raise any new issues of safety or effectiveness.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Den-Mat Holdings, LLC % Intertek Testing Services Ms. Paula Wilkerson 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
FEB 10 201
:
Re: K110079
Trade/Device Name: Sapphire Plus STM 3W Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 03, 2011 Received: February 07, 2011
Dear Ms. Wilkerson:
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. Insting 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.
の 2017年 10:00 PM 2017
.
.
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Page 2 – Ms. Paula Wilkerson
Please be advised that I'DA'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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kiy B. Reta
kr
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//079
Device Name: Sapphire Plus STM 3W Diode Laser
Indications for Use:
The Sapphire Plus STM 3W 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 fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision; 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; and vestibuloplasty.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
Page
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilbe Ogden for mxm
Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
. 510(k) Number K110079
