Dental 5 Multi Diode laser

K163638 · Bio-Med USA, Inc. · GEX · May 15, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163638
• Device Name: Dental 5 Multi Diode laser
• Applicant: Bio-Med USA, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.

Device Story

Dental 5 Multi is a GaAlAs semiconductor diode laser system; produces 810nm and 980nm infrared laser energy; includes switchable 650nm aiming beam. Physician operates device via display panel and foot pedal; laser energy delivered to oral soft tissue via fiber optic handpiece. Used for incision, ablation, vaporization, hemostasis of oral soft tissue; also used for light-activated tooth bleaching. Enables precise soft tissue management; benefits include controlled tissue removal and hemostasis during dental procedures.

Clinical Evidence

No clinical performance test data provided. Bench testing performed in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and IEC 62304 standards. Sterilization validation for reusable handpiece tips provided.

Technological Characteristics

Solid-state GaAlAs semiconductor diode laser; 810nm/980nm wavelengths; 650nm aiming beam; 5-7W power. Handpiece constructed of S.S.304 and ABS resin. Features fiber optic delivery, foot pedal control, and display panel. Sterilization via moist heat (autoclave). Complies with IEC 60601-1, 60601-1-2, 60601-2-22, 60825-1, and 62304.

Indications for Use

Indicated for oral soft tissue surgery (incision, ablation, vaporization, hemostasis) and laser-assisted tooth bleaching in patients requiring dental soft tissue procedures or 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

• DioDen Micro 810/980 (K063384)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

May 15, 2017

Bio-med Usa Inc Young Chi CEO 111 Ellison Street Paterson, New Jersey 07505

Re: K163638

Trade/Device Name: Dental 5 Multi 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: April 12, 2017 Received: April 17, 2017

Dear Young Chi:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 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 -A

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) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|--|
| K163638 | |
| LA PERSONALIZATIONAL PROPERTY PLANETH AND PLANET AND PLANET AND PLANET AND THE CHART COLLEGIAL CONTRACT COLLEGIAL CONTRACT COLLEGION<br>Device Name | |
| Dental 5 Multi | |

#### Indications for Use (Describe)

This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal,

Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal,

Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510 (K) Summary

As required by CFR 807.92(c)

- 1. Manufacturer.
Prepared Dec 12,2016

RegNr:3011555967

BISON Medical Co., Ltd. Ace High-end tower 6, #1801/1802, 234 Beotkkot-ro, Gasan dong, GeumCheon -gu, Seoul153-802, Rep ofKorea t:82 2 865 7121 f: 82 2 865 7131

2. Submitter and Contact person

Bio-Med USA Inc. YoungChi, C.E.O 111 Ellison Street, Paterson, NJ 07505. U.S.A. t:1-973-278-5222 f: 1 201934-6030 e mail:[e-mail]

Reg2246683

#### 3. Name of Device

| Trade name | Dental 5 multi |
|-----------------------|------------------------------------|
| Classification name : | Powered, Laser surgical instrument |
| Common name | Diode Laser for dental |
| Regulation | 878.4810 Class II |
| Classification Panel | General and Plastic Surgery. |
| Product Code | GEX |
| Type of submission | Traditional |

#### 4. Legally marketed Predicate Device

| K063384 | DioDen Micro 810/980 | Diode Laser Hoya ConBio, Inc |
|---------|----------------------|------------------------------|
|---------|----------------------|------------------------------|

Dental 5 Multi wave DiodeLaser system produce same two wave length (980nm, 810nm), and switchable 630nm Aiming beam with same characteristics such as Design, Construction, Energy rate, Pulse Duration, Cooling system and intended use as already cleared predicate device.

#### 5. Device Description

Dental 5 multi Diode laser system are producing 810 / 980+-10mm wave length Solid state Grallium Aluminum Arsenide (GaAIAs) semiconductor diode invisible infrared radiation as a laser energy, and also available switchable 650nm aiming beam with 5-7watts, the laser power is delivered to the treatment area via a fiber bendable optic tip to access all areas of the mouth

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the treatment beam and it is able to activate laser emission using foot pedal switch.

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Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

The delivery system consists of Autoclavable hand piece and foot pedal switch

#### 6. Performance test

Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard

1EC60601-1 part 1 : General requirement for basic safety and essential performance. IEC60601-1-2:2007 Electro Magnetic Compatibility test IEC 60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED, Equipment classification and requirement. ffiC62304 Medical device Software life-cycle processes

#### 7. Indication for use

Dental 5 Diode laser system is indicated for the Incision, Ablation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Unerupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingivar Incision and Excision, Implant recovery, Incision and drainage of abscess, Ieukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, light activation for bleaching material, for laser assisted bleaching/whitening for teeth.

#### 8.Sterilization, Disinfection

Hand piece tips are made by S.S.304 and ABS resin which are already cleared as Safety material, and bench test data, Safety material data attached.

*User moist Heat Sterilization Validation Report (Auto Clave)

* Validation Report of Cleaning and Disinfection process for re-usable medical device

#### 9. Conclusion.

Dental 5 multi Diode laser system, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use, Main function, Technology, Principal operation and performance.

And every Safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness.