LightMed Dental Laser System

K170073 · Lightmed Dentaltechnology Corp. · GEX · Jul 25, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170073
• Device Name: LightMed Dental Laser System
• Applicant: Lightmed Dentaltechnology Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).

Device Story

LightMed Dental Laser System is an Er:YAG solid-state laser (2940 nm) for intraoral dental/maxillofacial surgery. Device comprises control panel, system controller, laser applicator, power supplies, cooling module, water spray module, and footswitch. Laser energy delivered via handpiece with sapphire tips to treatment site. Operated by dental professionals in clinical settings. System transforms electrical energy into pulsed laser output via flashlamp pumping. Output used for incision, excision, ablation, vaporization, and coagulation of hard (tooth/bone) and soft tissues. Water spray module provides cooling during operation. Clinical benefit includes precise tissue management and improved periodontal indices. Healthcare providers use device to perform surgical procedures; output directly facilitates tissue removal or modification.

Clinical Evidence

Bench testing only. Device performance validated against federal and international standards including IEC 60825-1 (laser safety), AAMI/ANSI 60601-1 (electrical safety), IEC 60601-2-22 (laser surgical equipment), and ISO 10993 series (biocompatibility). No clinical data presented.

Technological Characteristics

Er:YAG solid-state laser; 2940 nm wavelength; flashlamp pumped; pulse system; max pulse energy 700 mJ; pulse duration < 800 µs; pulse rate up to 50 Hz; average power 0.5-8.4 W. Handpiece: aluminum alloy. Tips: sapphire. Class I ME equipment, Type BF. Microprocessor-controlled. Water spray module for cooling. Complies with IEC 60601-1, IEC 60601-2-22, IEC 62304, and ISO 10993.

Indications for Use

Indicated for oral and maxillofacial surgery and dentistry including caries removal, cavity preparation, enamel etching, pit/fissure excavation, bone shaving/contouring/resection, apicoectomy, osteotomy, osseous crown lengthening, soft tissue biopsies, gingival incision/excision, gingivoplasty, gingivectomy, implant recovery, frenectomy, fibroma removal, lesion removal, operculectomy, papillectomy, gingival hypertrophy reduction, soft tissue crown lengthening, preprosthetic surgery, sulcular debridement, and endodontal procedures (root canal access, pulpotomy, pulp extirpation, root canal debridement/cleaning/preparation).

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

• LITETOUCH Dental Laser System (K061966)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

July 25, 2017

LightMed Dental Technology Corp. Ms. April Cheng Regulatory Affairs Engineer 5F., No. 96, Luke 5th Rd., Luzhu Dist. Kaohsiung, Taiwan (R.O.C.) 821 Taiwan

Re: K170073

Trade/Device Name: LightMed Dental 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: June 23, 2017 Received: June 26, 2017

Dear Ms. Cheng

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

{1}------------------------------------------------

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 (OS) 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" (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 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 yours,

# Jennifer R. Stevenson -S3

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### Device Name

Lightmed Dental Laser System

#### Indications for Use (Describe)

The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).

The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry:

- · Hard Tissue Indications of Erbium Laser Energy:
- * Caries removal
- * Cavity preparation
- * Enamel etching
- * Excavation of pits and fissures for placement of sealant
- · Bone Indications of Erbium Laser Energy:
- * Shaving, contouring, and resection of oral osseous tissue (bone)
- * Apicoectomy amputation of the root end
- * Cutting bone to prepare a window access to the apex (apices) of the root(s)
- * Osteotomy
- * Osseous crown lengthening
- · Soft Tissue and Periodontal Indications of Erbium Laser Energy:
- * Excisional and incisional biopsies
- * Exposure of unerupted teeth
- * Incision and drainage of abscesses
- * Gingival incision and excision
- * Gingivonlasties
- * Gingivectomies
- * Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
- * Implant recovery
- * Frenectomies and frenotomies
- * Fibromatosis (fibroma removal)
- * Benign and malignant lesion removal
- * Operculectomy
- * Oral papillectomies
- * Reduction of gingival hypertrophy
- * Soft tissue crown lengthening

* Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, papillomas, fibromatoses benign growths, vestibuloplasty

* Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

- · Endodontal Indications of Erbium Laser Energy:
- * Tooth preparation to obtain access to root canal
- * Pulpotomy
- * Pulpotomy as an adjunct to root canal therapy
- * Pulp extirpation
- * Root canal debridement and cleaning

{3}------------------------------------------------

| * Root canal preparation including enlargement |
|------------------------------------------------|
|------------------------------------------------|

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Lightmed Dental. The logo consists of a blue abstract symbol on the left, followed by the word "LIGHTMED" in black, sans-serif font. Below "LIGHTMED" is the word "DENTAL" in white, set against a blue rounded rectangle.

#### Section 5 510(k) Summary

### I. SUBMITTER

LightMed Dental Technology Corp. 5F., No. 96, Luke 5th Rd., Luzhu Dist., Kaohsiung City, Taiwan, R.O.C. TEL: [phone] FAX: [phone] Contact Person: April Cheng / Regulatory Affairs Engineer Date Prepared: Jun 03, 2017

## II. DEVICE

Trade name: LightMed Dental Laser System Model name: Sapphire Classification name: Laser Instrument, Surgical, Powered Classification Panel: General & Plastic Surgery Regulation number: 21 CFR 878.4810, Class II Product code: GEX

#### III. PREDICATE DEVICE

Substantial equivalence to the following predicate device is as follows:

LITETOUCH Dental Laser System Decision Date:9/27/2006 K061966

# IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION

LightMed Dental Laser System is an erbium: yttrium aluminium garnet (Er: YAG) solid-state laser that provides optical energy at 2940 nm. LightMed Dental Laser System is a delicate integrate device of optical, mechanic, electronic, water and gas, which is consists of a control panel, system controller, laser applicator, power supplies and discharger, laser cooling module, spray water module, footswitch and external remote interlock connector. The laser console is embedded in the laser handpiece, delivers laser energy to the treatment site through a laser tip attached to a handpiece. The laser

1

EL-FDA-Summary-A2 lof7

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Lightmed Dental. The logo consists of a blue geometric shape resembling a stylized flower or starburst on the left. To the right of the shape, the word "LIGHTMED" is written in a bold, sans-serif font. Below "LIGHTMED", the word "DENTAL" is written in white letters inside a blue rounded rectangle.

is activated by means of a footswitch. Various laser tips are available for different clinical applications. The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).

# V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Trade name | LightMed Dental Laser System | LITETOUCH Dental Laser System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model name | Sapphire | LITETOUCH™ |
| 510(k)<br>number | K170073 | K061966 |
| Unit | 11.8 x 17.3 x 35.8 in<br>(30 x 44 x 91 cm) | 10.25 x 15.75 x 15.75 in<br>(26 x 40 x 40 cm) |
| Weight | 77 lbs (35 kg) | 44 lbs (20 kg) |
| Operating<br>Voltage | 100-230 VAC | 100-230 VAC |
| Electrical<br>Frequency | 50 / 60 Hz | 50 / 60 Hz |
| Electrical<br>Requirement | Single Phase | Single Phase |
| Current<br>Rating | 12 A | 13 A |
| Optical<br>Frequency | Up to 50 Hz | Up to 50 Hz |
| Spot Size | 0.2-1.0 mm (Tip dependent) | 0.2-1.0 mm (Tip dependent) |
| Tip category | 1. 1.3×19 mm<br>2. 1.3×14 mm<br>3. 1.0×17 mm<br>4. 0.8×14 mm<br>5. 0.6×17 mm<br>6. Side Firing 1.3×19 mm<br>7. Chisel | 1. 1.3 x 19 mm<br>2. 1.3 x 17 mm<br>3. 1.3 x 14 mm<br>4. 1.0 x 17 mm<br>5. 1.0 x 14 mm<br>6. 0.8 x 17 mm<br>7. 0.8 x 14 mm<br>8. 0.6 x 17 mm<br>9. 0.4 x 17 mm<br>10. Implants tips, 1.3 x 19 mm<br>11. Chisel tip |
| Laser Tip<br>Material | sapphire | sapphire |
| Handpiece<br>Material | Aluminum alloy | Aluminum alloy |
| Type of pro-<br>tection against<br>electrical<br>shock | Class I ME Equipment | Class I ME Equipment |
| Degree of pro-<br>tection against<br>electrical<br>shock | Type BF Equipment | Type BF Equipment |
| Laser<br>Classification | 4 | 4 |
| Laser Energy<br>Source | Er: YAG (Erbium: Yttrium-<br>Aluminium-Garnet) | Er: YAG (Erbium: Yttrium-<br>Aluminium-Garnet) |
| Wavelength | 2.94 µm (2940 nm) | 2.94 µm (2940 nm) |
| Pumping<br>Source | Flashlamp | Flashlamp |
| Delivery<br>Component | Applicator with reflector and optics | Applicator with reflector and optics |
| Pulsing<br>System | Pulse | Pulse |
| Pulse Rate | Up to 50Hz | Up to 50Hz |
| Average<br>Power | 0.5-8.4 W | 0.5-8.4 W |
| Maximum<br>Pulse Energy | 700 mJ | 700 mJ |
| Pulse<br>Duration | < 800 µs | < 800 µs |
| Device System | Sapphire is an advanced micropro-<br>cessor-controlled laser system, com-<br>posed of the following sub-systems:<br>• Control Panel<br>• System Controller<br>• Laser Applicator<br>• Water Spray Module | LiteTouch is an advanced micro-<br>processor-controlled laser system,<br>composed of the following sub-<br>systems:<br>• Control Panel<br>• System Controller<br>• Laser Applicator |
| | Power Supply and Discharger Laser Cooling Module Footswitch Remote Interlock Connector | Water Spray Module Power Supply and Discharger Laser Cooling Module Footswitch Remote Interlock Connector |
| Intended Use | <b>Hard Tissue Indications of Erbium Laser Energy:</b> Caries removal Cavity preparation Enamel etching Excavation of pits and fissures for placement of sealant <b>Bone Indications of Erbium Laser Energy:</b> Shaving, contouring, and resection of oral osseous tissue (bone) Apicoectomy - amputation of the root end Cutting bone to prepare a window access to the apex (apices) of the root(s) Osteotomy Osseous crown lengthening <b>Soft Tissue and Periodontal Indications of Erbium Laser Energy:</b> Excisional and incisional biopsies Exposure of unerupted teeth Incision and drainage of abscess- | <b>Hard Tissue Indications of Erbium Laser Energy:</b> Caries removal Cavity preparation Enamel etching Enameloplasty Excavation of pits and fissures for placement of sealant <b>Bone Indications of Erbium Laser Energy:</b> Contact and non-contact cutting Shaving, contouring, and resection of oral osseous tissue (bone) Apicoectomy - amputation of the root end Cutting bone to prepare a window access to the apex (apices) of the root(s) Osteoplasty Osteotomy Osseous crown lengthening <b>Soft Tissue and Periodontal Indications of Erbium Laser Energy:</b> Excisional and incisional biopsies Exposure of unerupted teeth Incision and drainage of abscess- |
| * Gingival incision and excision | * Gingival incision and excision | |
| * Gingivoplasties | * Gingivoplasties | |
| * Gingivectomies | * Gingivectomies | |
| * Gingivectomy in case of hyper-<br>plasias of the gingival or excision<br>of hyperplasias | * Gingivectomy in case of hyper-<br>plasias of the gingival or excision<br>of hyperplasias | |
| * Implant recovery | * Gingival troughing for crown im-<br>pressions | |
| • Frenectomies and frenotomies | * Hemostasis | |
| * Fibromatosis (fibroma removal) | * Implant recovery | |
| * Benign and malignant lesion re-<br>moval | • Frenectomies and frenotomies | |
| * Operculectomy | * Fibromatosis (fibroma removal) | |
| * Oral papillectomies | * Benign and malignant lesion re-<br>moval | |
| * Reduction of gingival hypertro-<br>phy | * Operculectomy | |
| * Soft tissue crown lengthening | * Oral papillectomies | |
| * Preprosthetic surgery: flabby al-<br>veolar ridge, vestibuloplasty, expo-<br>sure of implants, hyperplasia, epu-<br>lides, papillomas, fibromatoses be-<br>nign growths, vestibuloplasty | * Reduction of gingival hypertro-<br>phy | |
| * Sulcular debridement (removal of<br>diseased or inflamed soft tissue in<br>the periodontal pocket to improve<br>clinical indices including gingival<br>index, gingival bleeding index,<br>probe depth, attachment loss and<br>tooth mobility) | * Soft tissue crown lengthening | |
| | * Preprosthetic surgery: flabby al-<br>veolar ridge, vestibuloplasty, expo-<br>sure of implants, hyperplasia, epu-<br>lides, papillomas, fibromatoses be-<br>nign growths, vestibuloplasty | |
| | * Sulcular debridement (removal of<br>diseased or inflamed soft tissue in<br>the periodontal pocket to improve<br>clinical indices including gingival<br>index, gingival bleeding index,<br>probe depth, attachment loss and<br>tooth mobility) | |
| Endodontal Indications of Erbi- | Endodontal Indications of Erbi-…