(42 days)
Not Found
No
The document describes a laser system for dental procedures and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device's intended uses, such as cavity preparation, root canal disinfection, excision of pathological tissues, and treatment of canker sores, are all therapeutic in nature as they involve treating or alleviating medical conditions.
No
The device description and intended use/indications for use solely describe its application for therapeutic and surgical procedures within dentistry, such as cutting, removing, and preparing tissues. There is no mention of diagnostic functions like identifying or analyzing diseases or conditions.
No
The device description clearly states it is a laser system with hardware components including a console, laser head, power supply, cooling system, fiber cable, handpiece, and footswitch. While it includes a tablet PC as a control panel and mentions software verification and validation, it is fundamentally a hardware device with integrated software.
Based on the provided information, the Waterlase Express is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- Waterlase Express Function: The Waterlase Express is a laser system used for surgical procedures on hard and soft tissues within the oral cavity. It directly interacts with the patient's tissues for cutting, shaping, removing, and disinfecting.
- Intended Use: The listed indications for use clearly describe surgical procedures performed directly on the patient's body (cavity preparation, caries removal, bone cutting, soft tissue incision, etc.). While it mentions submitting tissue growth for histopathological evaluation (which is an in vitro process), the device itself is not used for this in vitro examination.
Therefore, the Waterlase Express is a surgical device used for direct treatment of the patient, not for the in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The Waterlase Express indications for use are as follows:
General Hard Tissue Indications (for use on adult and pediatric patients)
- 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
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
-
Laser root canal disinfection after endodontic treatment
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.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- Osteotomy
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, 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
- Implant recovery
- Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- 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 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)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- Osseous crown lengthening
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- Waterlase Er.Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Product codes
GEX
Device Description
Waterlase Express is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr.YSGG) solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. Waterlase Express utilizes advanced laser and water atomization technologies to cut. shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral hard tissues, oral soft tissues, pulpal tissues, root canal, bone, periodontal pocket
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)
The following performance data were provided in support of substantial equivalence determination:
Biocompatibility Testing: The biocompatibility evaluation for the Waterlase Express was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The battery of testing included cvtotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. The results demonstrate biocompatibility of the device.
Electrical Safety and Electromagnetic Compatibility (EMC): Safety testing of Waterlase Express was conducted according to recognized standards: IEC 60601-1-2 standard for EMC and IEC 60601-1. IEC 60601-2-22. IEC 60825-1 and IEC 80601-2-60 for safety. The device meets applicable requirements related to the above-referenced standards.
Software Verification and Validation: Software verification and validation testing was performed and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices and "Guidance for the Content of Premarket Submission for Management of Cybersecurity in Medical Devices". The results demonstrate that Waterlase Express performs according to specifications and functions intended.
Bench Testing: In-vitro testing was conducted on soft and hard tissue to evaluate performance between the subject device and its predicate. The results demonstrate that Waterlase Express performs as well as the predicate device, Waterlase MD Turbo Plus.
Clinical Testing: Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 right, with flowing lines above them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Biolase, Inc. Alicia Mszyca Manager, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K161669
Trade/Device Name: Waterlase Express 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 15, 2016 Received: June 16, 2016
Dear Alicia Mszyca:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Christopher J. Ronk -S
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) K161669
Device Name Waterlase Express
Indications for Use (Describe)
The Waterlase Express indications for use are as follows:
General Hard Tissue Indications (for use on adult and pediatric patients)
- · 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
Root Canal Hard Tissue Indications
- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- · Root canal debridement and cleaning
Root Canal Disinfection
-
· Laser root canal disinfection after endodontic treatment
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.
Bone Surgical Indications
- · Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, 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
3
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis
- Implant recovery
- · Incision and drainage of abscesses
- · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area
- during apical surgery
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- Pulpotomy
- · Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- · Root canal debridement and cleaning
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
- · 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 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)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- · Osseous crown lengthening
- · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- · Waterlase Er.Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Type of Use (Select one or both, as applicable)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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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:
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"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."
5
510(k) SUMMARY
I. SUBMITTER
Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: (949) 226-8471 Fax: (949) 273-6688 Contact Person: Alicia Mszyca Date Prepared: June 14, 2016
- II. DEVICE
| Name of Device: | Waterlase Express |
|---|---|
| Common Name: | Er,Cr:YSGG Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) |
| Device Class: | II |
| Product Code: | GEX |
III. PREDICATE DEVICE
Waterlase MD Turbo Plus, Biolase, Inc., K101658
DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.
Waterlase Express is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr.YSGG) solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. Waterlase Express utilizes advanced laser and water atomization technologies to cut. shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
6
INDICATIONS FOR USE V.
The Waterlase Express indications for use are as follows:
General Hard Tissue Indications (for use on adult and pediatric patients)
- . 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 ●
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement ●
- Root canal debridement and cleaning
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment .
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) o
- 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 o 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.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) 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 o
- Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth o (hard and soft tissue impactions)
- o Frenectomy and frenotomy
Biolase, Inc. Waterlase Express - 510(k) Submission
7
- Gingival troughing for crown impressions ●
- Gingivectomy ●
- Gingivoplasty
- Gingival incision and excision ●
- o Hemostasis
- Implant recovery
- Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area o during apical surgery
- Leukoplakia
- Operculectomy
- Oral papillectomies
- o Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- o Vestibuloplasty
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic o 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 o periodontal pocket
- o Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
- Removal of granulation tissue from bony defects
- o 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)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
Biolase, Inc.
Waterlase Express - 510(k) Submission
8
- Osseous crown lengthening
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- o Waterlase Er.Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Waterlase Express subject device and the Waterlase MD Turbo Plus predicate device are based on the same technological principles including:
- Solid-state Er, Cr;YSGG laser at 2780nm wavelength ●
- Laser is running at a free-running mode without any additional light modulation ● features
- o Output radiation is pulsed and can be controlled in multiple ways: energy per pulse, pulse duration and pulse repetition rate
- System contains air/water supply that allows controlled delivery of very precise ● water particles to the treatment site
- System is software-operated and the parameters are controlled by a control panel
The key differences between the subject and the predicate device include:
- Lower power output of the subject device compared to the predicate
- o Brighter aiming beam for better visibility of the treatment site with max power output of 3mW compared to the predicate device with 1mW aiming beam
- The subject device uses a detachable tablet PC as the control panel / user interface compared to an LCD touchscreen in the predicate device
- o The use of a wireless footswitch in the subject device compared to a connected footswitch in the predicate
- The subject device is a smaller table-top unit whereas the predicate device is a floor ● unit (cabinet)
Summary of technological characteristics between the subject and predicate device is presented in Table 1, below.
9
| | Subject Device | Predicate Device
(K101658) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Waterlase Express | Waterlase MD Turbo Plus |
| Manufacturer | Biolase | Biolase |
| Laser Medium | Er, Cr: YSGG | Er, Cr: YSGG |
| Laser Classification | IV(4) | IV(4) |
| Wavelength | 2780 nm | 2780 nm |
| Max Power Output | Up to 4.0 W | Up to 10.0 W |
| Output Mode | Pulsed | Pulsed |
| Max Pulse Energy | 200 mJ | 600 mJ |
| Fluence per Spot | 10-170 J/cm2 | 10-500 J/cm2 |
| Repetition Rate
(Frequency) | 5-50 Hz | 5-100 Hz |
| Spot Size | 200 - 1,200 μm | 200 - 1,200 μm |
| Pulse Duration (Width) | 60 μs, 700 μs | 60 μs, 700 μs |
| Aiming Beam | Diode laser, max 3 mW,
625-670 nm, Class 3R | Diode laser, max 1 mW,
635 nm, Class 1 |
| Operating voltage | 100 / 230 VAC | 100 / 230 VAC |
| Control Panel / User
Interface | Tablet PC | LCD Touchscreen |
| Footswitch | Wireless | Wired |
| Indications for Use | General Hard Tissue Indications
(for use in adult and pediatric
patients)
• 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 | General Hard Tissue Indications
(for use in adult and pediatric
patients)
• 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 |
Table 1: Comparison of Waterlase Express to Waterlase MD Turbo Plus
10
Root Canal Hard Tissue
Indications
- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment
Endodontic Surgerv (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.
Bone Surgical Indications
- · Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient)
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
Root Canal Hard Tissue Indications
- · Tooth preparation to obtain access to root canal
- · Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
- · Laser root canal disinfection after endodontic treatment
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.
Bone Surgical Indications
- · Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- · Osteotomy
Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient)
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including:
11
| • Excisional and incisional biopsies | • Excisional and incisional biopsies |
|---|---|
| • Exposure of unerupted teeth | • Exposure of unerupted teeth |
| • Fibroma removal | • Fibroma removal |
| • Flap preparation – incision of soft | • Flap preparation – incision of soft |
| tissue to prepare a flap and expose | tissue to prepare a flap and expose |
| the bone | the bone |
| • Flap preparation – incision of soft | • Flap preparation – incision of soft |
| tissue to prepare a flap and expose | tissue to prepare a flap and expose |
| unerupted teeth (hard and soft tissue | unerupted teeth (hard and soft tissue |
| impactions) | impactions) |
| • Frenectomy and frenotomy | • Frenectomy and frenotomy |
| • Gingival troughing for crown | • Gingival troughing for crown |
| impressions | impressions |
| • Gingivectomy | • Gingivectomy |
| • Gingivoplasty | • Gingivoplasty |
| • Gingival incision and excision | • Gingival incision and excision |
| • Hemostasis | • Hemostasis |
| • Implant recovery | • Implant recovery |
| • Incision and drainage of abscesses | • Incision and drainage of abscesses |
| • Laser soft tissue curettage of the | • Laser soft tissue curettage of the |
| post-extraction tooth sockets and | post-extraction tooth sockets and |
| the periapical area during apical | the periapical area during apical |
| surgery | surgery |
| • Leukoplakia | • Leukoplakia |
| • Operculectomy | • Operculectomy |
| • Oral papillectomies | • Oral papillectomies |
| • Pulpotomy | • Pulpotomy |
| • Pulp extirpation | • Pulp extirpation |
| • Pulpotomy as an adjunct to root | • Pulpotomy as an adjunct to root |
| canal therapy | canal therapy |
| • Root canal debridement and | • Root canal debridement and |
| cleaning | cleaning |
| • Reduction of gingival hypertrophy | • Reduction of gingival hypertrophy |
| • Soft tissue crown lengthening | • Soft tissue crown lengthening |
| • Treatment of canker sores, herpetic | • Treatment of canker sores, herpetic |
| and aphthous ulcers of the oral | and aphthous ulcers of the oral |
| mucosa | mucosa |
| • Vestibuloplasty | • Vestibuloplasty |
| • Removal of pathological tissues | • Removal of pathological tissues |
| (i.e., cysts, neoplasm or abscess) | |
| and hyperplastic tissues (i.e., | (i.e., cysts, neoplasm or abscess) |
| and hyperplastic tissues (i.e., | |
| granulation tissue) from around the | granulation tissue) from around the |
| apex | apex |
| NOTE: Any tissue growth (i.e., cyst, | NOTE: Any tissue growth (i.e., cyst, |
| neoplasm or other lesions) must be | neoplasm or other lesions) must be |
| submitted to a qualified laboratory | submitted to a qualified laboratory |
| for histopathological evaluation. | for histopathological evaluation |
12
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VII. PERFORMANCE DATA
The following performance data were provided in support of substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for the Waterlase Express was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The battery of testing included cvtotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. The results demonstrate biocompatibility of the device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Safety testing of Waterlase Express was conducted according to recognized standards: IEC 60601-1-2 standard for EMC and IEC 60601-1. IEC 60601-2-22. IEC 60825-1 and IEC 80601-2-60 for safety. The device meets applicable requirements related to the above-referenced standards.
Software Verification and Validation
Software verification and validation testing was performed and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices and "Guidance for the Content of Premarket Submission for Management of Cybersecurity in Medical Devices". The results demonstrate that Waterlase Express performs according to specifications and functions intended.
Bench Testing
In-vitro testing was conducted on soft and hard tissue to evaluate performance between the subject device and its predicate. The results demonstrate that Waterlase Express performs as well as the predicate device, Waterlase MD Turbo Plus.
Clinical Testing
Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent.
VIII. CONCLUSION
Waterlase Express is substantially equivalent to its legally marketed predicate device, Waterlase MD Turbo Plus, in technical characteristics, operating principle and mechanism of action. It has the same indications for use and equivalent performance. Therefore, it can be concluded that Waterlase Express is as safe and effective as the predicate device.