D-STORM 810NM, D-STORM 980NM

K093048 · Light Instruments · GEX · Mar 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093048
• Device Name: D-STORM 810NM, D-STORM 980NM
• Applicant: Light Instruments
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The D-Storm diode laser system is indicated for: Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. Light activation of bleaching materials for teeth whitening. The D-Storm specific indications include the following: Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision 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 aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Device Story

D-STORM Diode Laser System is a microprocessor-controlled laser for oral/maxillofacial surgery and dentistry. System components include control panel, diode laser, safe system control, cooling system, hand-piece, and foot panel. Device operates by delivering laser energy to soft tissue for incision, excision, ablation, vaporization, coagulation, or to activate bleaching materials. Used in clinical dental settings by trained professionals. Output is controlled laser energy; healthcare providers use this to perform precise tissue management or whitening procedures. Benefits include improved surgical precision and hemostasis compared to traditional methods.

Clinical Evidence

No clinical data. Safety and efficacy are established via scientific research and literature regarding diode laser devices with wavelengths of 0.81 and 0.98 microns and power up to 7 Watts. Bench testing and compliance with recognized safety standards (EN 60601-1, EN 60825-1, IEC 60601-1-2) were used to support the application.

Technological Characteristics

Microprocessor-controlled diode laser system. Class IV laser product. Wavelengths: 0.81 and 0.98 microns. Power: up to 7 Watts. Includes control panel, cooling system, hand-piece, and foot panel. Complies with 21 CFR 1040.10, 21 CFR 1040.11, EN 60601-1, EN 60825-1, EN 60601-2-22, and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring soft tissue oral and maxillofacial surgery or dental procedures, including incision, excision, ablation, and coagulation, as well as light-activated 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

• LITEDUO (K073411)
• DioDent Micro (K063384)
• FOTONA XD (K083034)

Submission Summary (Full Text)

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# 510(K) SUMMARY

# D-STORM Diode Laser System 510(k) Number K_09304

| Applicant's Name: | Light instruments Ltd | |
|-------------------|-----------------------|--------------|
| | Tavor Building 1 | |
| | Yokneam Ind. Zone | |
| | P.O.Box 223 | |
| | Yokneam Elite 20692 | MAR 2 3 2010 |
| | Tel: [phone] | |
| | Fax: [phone] | |

| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda St.<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|

D-STORM Diode Laser System Classification: Name: Laser Instrument, Surgical, Powered Product Code: GEX Regulation No: 21 CFR 878.4810 Class: II

Panel: General & Plastic Surgery

#### Device Description:

Trade Name:

The D-STORM Diode Laser is an advanced microprocessor-controlled laser system, composed of the following units:

- Control panel; .
- . Diode laser
- Safe System Control .
- . Cooling System
- A hand-piece and foot panel; .

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D-STORM Dental Laser System – 510k Notification

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## Intended Use Statement:

The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

The D-Storm diode laser system is indicated for

- . Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
- Light activation of bleaching materials for teeth whitening. .

The D-Storm specific indications include the following:

Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision 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 aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Substantial equivalence to the following predicate devices is claimed: Predicate Devices:

| Device Name | Manufacture | 510k No | Clearance Date |
|---------------|-----------------------|---------|----------------|
| LITEDUO | Light Instruments Ltd | K073411 | May 13, 2008 |
| DioDent Micro | Hoya Conbio, Inc | K063384 | March 16, 2007 |
| FOTONA XD | FOTONA | K083034 | Feb 04, 2009 |

#### Performance Standards

D-STORM Diode Laser System complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products. In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:

- . EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
- . EN 60825-1 (Safety of laser products);

D-STORM Dental Laser System - 510k Notification

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- EN 60601-2-22 (Medical device equipment, Particular Requirements . for the safety and diagnostics and therapeutic laser equipment).
- IEC 60601-1-2 (Electromagnetic compatibility (EMC) .

A detailed description appears in Section 14.

## Summary of Clinical performance data

The safety and efficacy of Diode Laser devices with wavelength of 0.81, 0.98 micron and power up to 7 Watts are well established in scientific research and literature including procedures performed in soft oral tissue, Cosmetic Endodontology and Periodontology.

Due to the comprehensive clinical study performed in scientific research and published in literature, and since the power, wavelength, pulse duration and frequency of the D-STORM Diode Laser System are well within the previous cleared values, Light Instruments believes that clinical studies are not required to determine the safety and efficacy of the device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 2 3 2010

Light Instruments, Ltd. % Osite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

Re: K093048

Trade/Device Name: D-STORM Diode Laser System 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: January 25, 2010 Received: January 29, 2010

Dear Mr. Levy:

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

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Page 2 - Mr. Yoram Levy

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 [phone] or [phone] or at its Internet address

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

Sincerely vours.

Sincerely yours,

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): | K093048 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | D-Storm Diode Laser System |
| Indications for Use: | The D-Storm system is intended to aid during dental procedures<br>performed in oral and maxillofacial surgery and dentistry.<br>The D-Storm diode laser system is indicated for:<br><ul><li>Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry</li><li>Light activation of bleaching materials for teeth whitening</li></ul> |
| | The D-Storm specific indications include the following:<br>Marginal and interdental gingiva and epithelial lining of free gingiva. |

frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and abscesses. tissue retraction, for impressions, draining of papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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D-STORM Dental Laser System 2 Stok T