(170 days)
K#041710, K#101658
Not Found
No
The summary describes a laser device for dental surgery and does not mention any AI or ML capabilities. The device description focuses on the laser technology and its interaction with tissues.
Yes
The device is intended for various dental surgical procedures involving incision, excision, vaporization, ablation, and coagulation of soft and hard tissues, which are all therapeutic actions aimed at treating conditions.
No
The device is described as a treatment and coagulation laser used for surgical procedures on soft and hard tissues in dentistry, not for diagnosis.
No
The device description explicitly states it is a "mobile Er: YAG Medical Treatment and Coagulation Laser of model MEY-1-A," which is a hardware device that emits a laser beam for surgical procedures. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a laser used for surgical procedures directly on the patient's hard and soft tissues in the oral cavity. It performs actions like incision, excision, vaporization, ablation, and coagulation.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. Its function is to interact directly with the patient's tissues.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and dentistry and for the ablation and vaporization of hard tissue in dentistry.
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, etc.)
- Osseous crown lengthening
- Removal of subgingival calculus
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#041710, K#101658
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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: +81-75-611-2141 Facsimile: +81-75-605-2354 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 |
| plastic surgery and in dermatology | |
| (21CFR878.4810) | |
| Product Code : | GEX |
| Intended Use : | Device is intended for the incision, excision, vaporization, |
| 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: 949-581-9600 | +81-75-611-2141 |
| Facsimile: 949-581-9688 | +81-75-605-2354 |
283
1
K120377
pg 2 of 4
- 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
2
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
3
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.
-
- 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".
-
- 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)
4
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
5
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 (800) 638-2041 or (301) 796-7100 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
6
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
8
- · 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
9
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