DIODE LASER THERAPY SYSTEM

K102669 · China Daheng Group, Inc. · GEX · Nov 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102669
• Device Name: DIODE LASER THERAPY SYSTEM
• Applicant: China Daheng Group, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications: - Incision - Excision - Vaporization - Ablation - Coagulation.

Device Story

DenLase-810/7 and DenLase-980/7 are compact, portable dental diode laser systems. Device utilizes semiconductor diode (AlGaAs) to generate invisible infrared laser radiation at 810nm or 980nm. Laser energy is delivered to oral soft tissue via flexible fiber and handpiece; activation controlled by footswitch. System includes semiconductor refrigeration. Operator selects from three operation modes (continuous, single pulse, continuous pulse) with adjustable power, pulse width, and pulse interval; five parameter combinations can be saved. Used by dental professionals in clinical settings for soft tissue procedures (e.g., gingivectomy, frenectomy, hemostasis, biopsy). Output allows for fast, accurate tissue/lesion disposal, aiding clinical decision-making by providing precise surgical control and coagulation. Benefits include minimally invasive soft tissue management.

Clinical Evidence

Bench testing only. No clinical data required. Validation performed against IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10 to verify design specifications and safety compliance.

Technological Characteristics

Semiconductor diode (AlGaAs) laser source; 810nm or 980nm wavelengths. Delivery via flexible fiber and handpiece. Semiconductor refrigeration. Modes: continuous, single pulse, continuous pulse. Adjustable power, pulse width, pulse interval. Standards: IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10. Footswitch activation.

Indications for Use

Indicated for intraoral soft tissue surgical applications including incision, excision, vaporization, ablation, and coagulation in patients requiring dental soft tissue procedures.

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

• Odyssey Navigator Diode Laser (K062258)
• KaVO GENTLEray 980 (K072262)
• Picasso (K083142)
• SiroLaser (K053161)

Submission Summary (Full Text)

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# Section III. 510(k) Summary

## Diode Laser Therapy System

NOV 1 7 2010

China Daheng Group, Inc.

### (As required by 21 CFR 807.92)

#### K Number: K102669

#### 1. Date Prepared: July 26, 2010

### 2. Sponsor Information

China Daheng Group, Inc. 15/F, North Section, Daheng Scitech Mansion, No.3 Suzhou Street, Haidian District, Beijing, 100080, China

Contract Person: Yu Wang, Sales Director Phone: [phone] - 243 Fax: [phone]

### 3. Submission Correspondent

Ms. Diana Hong Mr. Tarzan Wang Shanghai Mid-Link Business Consulting Co., Ltd P.O. BOX 237-023 Shanghai, 200237, China Tel: [phone] Fax:[phone] Email: [e-mail]

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### 4. Proposed Device Information

Device Common or Usual Name: Dental diode laser; Device Trade or Proprietary Name: Diode Laser Therapy System Classification Name: Laser instrument, Surgical, Powered Regulation Number: 21 CFR 878.4810 Product Code: GEX Panel: 878 General and Plastic Surgery Model: DenLase-810/7; DenLase-980/7

#### 5. Predicate Device

Odyssey Navigator Diode Laser ( K062258) Manufactured by IVOCLAR VIVADENT, INC.

KaVO GENTLEray 980 (K072262) Manufactured by KAVO AMERICA

Picasso (K083142) Manufactured by AMD LASERS, LLC

SiroLaser(K053161) Manufactured by SIRONA DENTAL SYSTEMS GMBH

#### 6. Device Description

Denlase Dental Laser Therapy System are new devices for 510(k) submission and share the similar indication for use and safety compliance, similar design features and functional features with the predicate devices.

The DenLase is a surgical device designed with compactness, portability, reliability and user-friendliness. It provides the operator with a tool for surgical and cosmetic procedures on oral soft tissue. The Denlase utilizes a semiconductor diode with invisible infrared radiation as a laser source (810nm or 980nm). The laser power is delivered to the treatment area via a flexible fiber, which has a handpiece. The emission laser is activated by a footswitch.

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The Denlase adopts advanced semiconductor lasers (AIGAAs) and semiconductor refrigeration technology. By laser sent out by optical fiber, it can fast and accurately dispose tissue and lesion. The device includes three operation modes as continuous. single pulse and continuous pulse, and each operation mode is adjustable respectively by three parameter of emitting power, pulse width and pulse interval. The user can save total five groups of operation mode parameter combination under different mode.

Based on this, the Dental Laser Therapy System is laser indicated for use in surgical applications including Pulposis, Periodontal disease, Diseases of oral mucosa, Oral and Maxillofacial Diseases, Salivary gland disease, Cosmetic Dentistry.

| Intended | Mode | Recommended Wavelength | Power Length | Power Interval |
|--------------------------------------------------|---------------|------------------------|--------------|----------------|
| Abscess | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Aphthous Ulcer | 810/7 & 980/7 | 810nm, 980nm | 200 μs | 200 μs |
| Bleaching | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Crown Lengthening | 810/7 & 980/7 | 980nm | 50 μs | 200 μs |
| Curettage | 810/7 | 810nm | 100 μs | 200 μs |
| devridement of deseased<br>epithelial lining | 980/7 | ,980nm | 100 μs | 200 μs |
| Exposure of Underpted<br>teeth | 810/7 | 810nm | 50 μs | 200 μs |
| Excision/Incisions | 810/7 & 980/7 | 810nm, 980nm | 50 μs | 200 μs |
| Frenectomy | 810/7 & 980/7 | 810nm, 980nm | 100 μs | 200 μs |
| Gingivectomy | 810/7 & 980/7 | 810nm, 980nm | 50 μs | 200 μs |
| Hemostasis | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Implant Recovery | 810/7 & 980/7 | 810nm, 980nm | 50 μs | 200 μs |
| Troughing | 810/7 & 980/7 | 810nm, 980nm | 100 μs | 200 μs |
| Biopsy | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Fibroma | 810/7 | 810nm | CW | --- |
| Gingivoplasty | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Herpes | 810/7 | 810nm | 200 μs | 200 μs |
| Hyperplasia | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Pulpotomy as an Adjunct<br>to Root Canal Therapy | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Leukoplakia | 810/7 & 980/7 | 810nm, 980nm | 200 μs | 200 μs |
| Mucoceles | 810/7 | 810nm | CW | --- |
| Partially Erupted Teeth | 980/7 | 980nm | 50 μs | 200 μs |
| Papillectomy | 980/7 | 980nm | CW | --- |

Table III-1 Recommendation Clinical Application

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510(k) Report for Diode Laser Therapy System - Section III 510(k) Summary

| Operculectomy | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
|---------------------------|---------------|--------------|----|-----|
| Vestibuloplasty | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Pulpotomy | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Sulcular debridement | 810/7 & 980/7 | 810nm, 980nm | CW | --- |
| Tooth Whitening/bleaching | 810/7 & 980/7 | 810nm, 980nm | CW | --- |

## 7. Intended use

The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications:

- Incision
- · Excision
- · Vaporization
- Ablation
- · Coagulation.

## 8. Substantial Equivalence

Denlase Dental Laser Therapy System shares the similar indications for use, design features, functional features, same safety compliance. Therefore the proposed device is substantially equivalent (SE) to the predicate devices.

The differences between the subject device and predicate device as following:

| Dimension<br>(H×W×D) | 19.0×13.0×18.0<br>cm | 9 1/2"×6"×4" | 17×26×18cm | 15 × 16 ×<br>23cm | 87 × 54 × 190<br>mm |
|-----------------------|----------------------|--------------------------------------------------------|---------------------|-------------------|---------------------|
| Weight | 1.5kg | 2.5 lb | 3.5 Kg | Less than 2 lb | 450 g |
| Duty Cycle | 1: (600000 to<br>1) | pulsed mode<br>50%<br>continuous<br>wave 100%<br>(1:1) | 1: (200000 to<br>1) | / | 2:1 to 1200:1 |
| Frequency of<br>Pulse | 0-10kHz | fixed 10 Hz | 2 to 20 kHz | 1-10000Hz | / |

Table III-2

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For the difference of dimension and weight, although the subject device has some differences with the predicates, but the subject device meet the same safety and performance standard with the predicates, so it has the same safety and effectiveness with predicate.

For the difference of duty cycle and frequency of pulse, although the subject device has tiny differences with the predicates. but the subject device meet all performance standard, such as IEC60825-1, IEC60601-2-22, so there are no marked difference with predicates.

#### 9. Testing

Denlase Dental Laser Therapy System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

- IEC 60825-1: Safety of laser products Part 1: Equipment classification, ● requirements and user's guide.
- IEC 60601-2-22: Medical Electrical Equipment Part 2: Particular requirements ● for the safety of diagnostic and therapeutic laser equipment.
- IEC 60601-1: Medical Electrical Equipment Part1: General requirements for . safety.
- IEC60601-1-2: Medical Electrical Equipment Part 1: General requirements for ● safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
- ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro . cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity

Non-Clinical Conclusion:

III-S

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#### 510(k) Report for Diode Laser Therapy System – Section III 510(k) Summary

Laboratory testing was conducted to validate and verify that the proposed device, Denlase Dental Laser Therapy System met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is written in a simple, sans-serif font. The logo is black and white.

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

China Daheng Group, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

NOV 1 7 20:0

Re: K102669 Trade/Device Name: Diode Laser Therapy System DenLase-810/7; DenLase-980/7 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: November 1, 2010 Received: November 5, 2010

Dear Mr. Devine:

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 Devices mark 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 provisions of a approval applicians of the 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 misledding.

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 Eederal Register.

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Page 2- Mr. Devine

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 Ass stance at its tollom of number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102669

510(k) Report for Diode Laser Therapy System - Section II Indication for Use Statement

## Section II. Indications for Use Statement

510(k) Number: Device Name:

K102669

NOV 1 7 2010

. 4

Diode Laser Therapy System DenLase-810/7;DenLase-980/7

Indications for Use:

The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications:

- Incision
- · Excision
- · Vaporization
- · Ablation
- · Coagulation.

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RS Betz DDS for Mr. Susan Runner

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 1

510(k) Number: K102669 Page 1 of 1

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