ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A

K120377 · J. Morita USA, Inc. · GEX · Jul 25, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120377
• Device Name: ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
• Applicant: J. Morita USA, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and dentistry

Device Story

Mobile Er:YAG laser system (MEY-1-A) for dental surgery in hospital environments. Emits 2.94 µm infrared beam absorbed by water in hard/soft tissues; causes instant vaporization of water molecules, leading to tissue ablation or resection. Operated by dental professionals. Output is laser energy for incision, excision, vaporization, ablation, and coagulation. Benefits include precise tissue removal and hemostasis. Differences from predicates include display, power calibration, and software, deemed minor.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards demonstrated.

Technological Characteristics

Er:YAG laser; 2.94 µm wavelength; Class 4 medical laser. Mobile form factor. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. Software-controlled power calibration and display.

Indications for Use

Indicated for adult and pediatric patients for hard tissue procedures (cavity prep, caries removal, enameloplasty, root canal prep/debridement, bone surgery, apicoectomy, periodontal procedures) and soft tissue procedures (biopsies, frenectomy, gingivectomy, hemostasis, pulpotomy, and treatment of oral ulcers).

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

• VERSAWAVE DENTAL ER: YAG LASER SYSTEM (K041710)
• WATERLASE MD TURBO PLUS MODEL 7200XXX (K101658)

Submission Summary (Full Text)

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K120377
pg 1 of 4

## JUL 2 5 2012

# 510(k) summary

Company name and address :

Date of preparation: Contact:

J.MORITA MFG. CORP. 680 Higashihama Minami cho Fushimi-ku, Kyoto, Japan Telephone: [phone] Facsimile: [phone] April 10, 2012 Yoshihide Okagami · General Manager of Technical Administration

and for the ablation and vaporization of hard tissue in

#### 1 . NAME OF DEVICE and Intended Use/Indications of Use

| Trade or Proprietary Name: | AdvErL EVO Er: YAG Laser for Dentistry |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | Model: MEY-1-A |
| | Note: The name is referred to as " MEY-1-A" hereafter. |
| Common Name: | Dental medical laser equipment |
| Usual Name: | Medical laser system |
| Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21CFR878.4810) |
| Product Code : | GEX |
| Intended Use : | Device is intended for the incision, excision, vaporization,<br>ablation and coagulation of soft tissue in oral and dentistry |

Predicate devices and Indications of use:

The MEY-1-A is substantially equivalent to both predicate devices of "VERSAWAVE DENTAL ER: YAG LASER SYSTEM ( K#041710) " made by HOYA CONBIO and WATERLASE MD TURBO PLUS MODEL 7200XXX( K#101658)" made by BIOLASE TECHNOLOGY, INC.

dentistry.

The indications of use of the MEY-1-A covers all identical indications of " VERSAWAVE DENTAL ER:YAG LASER SYSTEM ( K#041710 ) " , however, lacks the indications of "Root canal indications / Laser root canal disinfection after endodontic" which is included in the indications of "WATERLASE MD TURBO PLUS MODEL 7200XXX( K#101658)

As for details of indications refer to FOOT NOTE of this summary ..

#### ESTABLISHMENT REGISTRATION NUMBER 2.

| Registration No. 2081055 | Registration No. 3002807636 |
|--------------------------|-----------------------------|
| Initial Distributor: | Manufacturer: |
| J. MORITA USA, INC. | J. MORITA MFG. CORP. |
| 9 Mason | 680 Higashihama Minami-cho |
| Irvine, CA 92618 | Fushimi-ku, Kyoto |
| USA | Japan 612-8533 |
| Telephone: [phone] | [phone] |
| Facsimile: 949-581-9688 | [phone] |

283

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K120377
pg 2 of 4

3. DEVICE CLASSIFICATION / CLASSIFICATION PANEL Device classification: Class 2 medical devise 21CFR878,4810 Laser surgical instrument for use in general and plastic surgery and in dermatology Laser classification: Class 4 medical laser product Per 21CFR 1040.10 and per 21CFR 1040.11 Device classification panel: 76 Dental

#### 4. PERFORMANCE STANDARDS

We examine the performance of the MEY-1-A by using the international standards:

| IEC 60601-1:2005 | Medical electrical equipment Part 1: General requirements for basicsafety and essential performance |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-22 | Medical electrical equipment Part 2: Particular requirements for safety of diagnostic and therapeutic laser equipment |
| IEC 60825-1 | Safety of laser products-Part 1: Equipment classification and requirements |
| IEC 60601-1-2:2007 | Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility -equipments and tests Edition 3) |

#### DEVICE DESCRIPTION and SUBSTANTIAL EQUIVALENCE 5.

#### A. DEVICE DESCRIPTION

#### General Product Information

Equipment is mobile Er: YAG Medical Treatment and Coagulation Laser of model MEY-1-A intended to be used for dental surgery in hospital environment.

Er.YAG Laser emits an infrared beam with a wavelength 2.94 um which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, a energy of the laser beam instantly vaporized the water molecules in hard tissues of the tooth causing the tissues to crumble away or resection of the soft tissues of gingival.

#### B. SUBSTANTIAL EQUIVALENCE

Company's proposal for establishing substantial equivalence of the MEY-1-A by demonstrating Comparison Table where the MEY-1-A is compared with two different predicate devices.

As a result of this comparison, the MEY-1-A has not only the same " intended use and Indications of use", but also has the substantially same " equivalent technical specifications" compared with the predicate device I ( Versa Wave Dental Er: YAG Laser System K#041710 ) and the predicate device II (WaterLase MD Turbo Plus MODEL 7200XXX : K#101658 }.

There are some differences in respects of display, power calibration and software, however, these are esteemed to be minor differences since we presume that they use similar existing technology with ours to realize their functions in each design stage, so that such slight difference would not cause substantial impacts to effectiveness or safety problems.

284

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## FOOT NOTE:

## Indications for Use Statement

AdvErL EVO Er: YAG Laser for Dentistry Device Name: Model: MEY-1-A

#### Indications for Use:

Hard Tissue

General Indications*

- · Class I, II, III, IV and V cavity preparation
- · Caries removal
- · Hard tissue surface roughening or etching
- · Enameloplasty, excavation of pits and fissures for placement of sealants
- * For use on adult and pediatric patients

Root Canal Hard Tissue Indications

- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- · Root canal debridement and cleaning

Bone Surgical Indications

- · Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy

Endodontic Surgery (Root Amputation) Indications

- · Flap preparation incision of soft tissue to prepare a flap and expose the bone.
- · Cutting bone to prepare a window access to the apex (apices) of the root(s).
- · Apicoectomy amputation of the root end.
- · Root end preparation for retrofill amalgam or composite.

· Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues(i.e., granulation tissue) from around the apex.

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Laser Periodontal Procedures

- · Full thickness flap
- · Partial thickness flap
- · Split thickness flap
- · Laser soft tissue curettage

· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Removal of granulation tissue from bony defects

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

· Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)

· Ostectorny (resection of bone to restore bony architecture, resection of bone for grafting,

285

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K120377
pg 4 of 4

etc.)

- · Osseous crown lengthening
· Removal of subgingival

Soft Tissue Indications including Pulpal Tissues*

Incision, excision, vaporization, ablation and coaqulation of oral soft tissues, including:

- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- Fibroma removal

· Flap preparation - incision of soft tissue to prepare a flap and expose the bone.

- · Flap preparation incision of soft tissue to prepare a fiap and expose unerupted teeth (hard and soft tissue impactions)
· Frenectomy and frenotomy

- · Gingival troughing for crown impressions
- · Gingivectomv
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Implant recoverv
- · Incision and drainage of abscesses
- · Incision and drainage of periapical abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area

during apical surgerv

- · Leukoplakia
- · Operculectomy
- Oral papillectomies
- · Pulpotomy
- · Pulp extirpation
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex .
- NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- · Root canal debridement and cleaning
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpe tic and aphthous ulcers of the oral mucosa
- · Vestibuloplastv
- * For use on adult and pediatric patients

N.B.

- 1) The abovementioned indications of use of the MEY-1-A is same to all the terms of " VERSAWAVE DENTAL ER:YAG LASER SYSTEM (K#041710)" except " Removal of subgingival calculus".
- 2) On the other hand, the indications of use of the MEY-1-A lacks the indication of "Root canal indications / Laser root canal disinfection after endodontic" which is included in the indications of "WATERLASE MD TURBO PLUS MODEL 7200XXX( K#101658)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

J. Morita USA, Incorporated % Fish & Richardson P.C. Mr. Keith A. Barritt 1425 K. Street Northwest Suite 1100 Washington, District of Columbia 20005

JUL 25 2012

## Re: K120377

Trade/Device Name: AdvErl EVO ER: YAG laser for Dentistry Model: MEY-1-A 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: July 13, 2012 Received: July 16, 2012

## Dear Mr. Barritt:

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

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# Page 2- Mr. Keith A. Barritt

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/ReportalProblem/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.

Eunil Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use statement

510(K) Number: K120377

AdvErL EVO Er: YAG Laser for Dentistry Device Name:

Model: MEY-1-A

Indications for Use:

Hard Tissue

General Indications*

· Class I, II, III; IV and V cavity preparation

· Caries removal

· Hard tissue surface roughening or etching

· Enameloplasty, excavation of pits and fissures for placement of sealants

* For use on adult and pediatric patients

Root Canal Hard Tissue Indications

· Tooth preparation to obtain access to root canal

· Root canal preparation including enlargement

· Root canal debridement and cleaning

Bone Surgical Indications

· Cutting, shaving, contouring and resection of oral osseous tissues (bone)

· Osteotomy

Endodontic Surgery (Root Amputation) Indications

· Flap preparation - incision of soft tissue to prepare a flap and expose the bone.

· Cutting bone to prepare a window access to the apex (apices) of the root(s).

· Apicoectomy - amputation of the root end.

· Root end preparation for retrofill amalgam or composite.

· Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex.

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. (Division Sign-Off)

Laser Periodontal Procedures

· Full thickness flap

· Partial thickness flap

· Split thickness flap

· Laser soft tissue curettage

· Laser removal of diseased, inflamed and necrosed soft tissue within

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

for
man

K12037

{7}------------------------------------------------

periodontal pocket

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium

· Removal of granulation tissue from bony defects

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

· Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiological osseous contours)

· Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)

- · Osseous crown lengthening
- · Removal of subgingival calculus

Soft Tissue Indications including Pulpal Tissues*

Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Flap preparation incision of soft tissue to prepare a flap and expose the bone.
- · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth
- (hard and soft tissue impactions)
- · Frenectomy and frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- Hemostasis and coagulation
- · Implant recovery
- · Incision and drainage of abscesses
- · Incision and drainage of periapical abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- · Pulpotomy

Nailk Qal for mkn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

290

510(k) Number K120377

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- · Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy

· Reduction of gingival hypertrophy

• Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex .

NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

• Root canal debridement and cleaning

· Soft tissue crown lengthening

· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa

· Vestibuloplasty

* For use on adult and pediatric patients

Nekrp Ogden forman

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

510(k) Number K120377

291

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Prescription Use_X (Part21CFR801 Subpart D)

## AND/OR

Over The Counter Use (Part21CFR807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off)

. .

Division of Surgical, Orthopedic, and Restorative Devices.

510(K) Number: K120377

Neil RPDgden forman

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

510(k) Number K120377