(239 days)
Not Found
No
The summary describes a laser system with a microprocessor for control and a user interface. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML technology in medical devices. The performance studies focus on biocompatibility, electrical safety, software validation (standard for medical devices), and bench testing related to the laser's physical effects.
Yes.
The device is used for treating various oral hard and soft tissue conditions, including caries removal, root canal disinfection, removal of pathological tissues, and periodontal procedures, all of which are considered therapeutic applications.
No
Explanation: The Waterlase Laser System Family is described as a treatment device used for cutting, shaving, contouring, roughening, etching, and resecting oral hard and soft tissues. Its intended uses are primarily surgical and therapeutic procedures, such as cavity preparation, root canal debridement, bone cutting, and various soft tissue incisions and excisions. There is no mention of it being used to identify or characterize a disease, condition, or health status.
No
The device description clearly states it is a "Waterlase Laser System Family" which utilizes a solid-state laser, power supply, cooling system, fiber optic cable, handpiece, and footswitch. These are all hardware components, making it a hardware-based medical device with integrated software.
Based on the provided information, the Waterlase Laser System Family is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's oral hard and soft tissues (cavity preparation, caries removal, bone cutting, soft tissue incision, etc.). IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details a laser system that delivers energy to the treatment site in the mouth. It does not mention any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on the device's safety and efficacy in performing surgical and therapeutic procedures on the patient, such as biocompatibility, electrical safety, software validation, and bench testing related to tissue interaction and thermal effects. There are no studies related to the analysis of biological specimens.
Therefore, the Waterlase Laser System Family is a therapeutic and surgical device used directly on the patient, not an IVD device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
Waterlase laser removal of porcelain and ceramic crowns and veneers
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, 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
- · 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 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780mm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications.
A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, 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. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral hard and soft tissue dental applications, root canal, bone, pulpal tissues, 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)
Biocompatibility Testing
The biocompatibility evaluation has been performed in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The battery of testing included cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. The results demonstrate biocompatibility of the patient-contacting components of the device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing conducted for the Waterlase Laser System Family demonstrate compliance with the current revisions of the recognized standards including IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60 and IEC 60601-1-2.
Software Verification and Validation
Software verification and validation has been conducted, and documentation provided in accordance with the Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. The results demonstrate that the Waterlase Laser System Family performs according to specifications and functions intended. The software design complies with the IEC 62304 standard - Medical device software- software life cycle processes.
Bench Testing
Performance bench testing has been completed to determine safety and efficacy when using a laser to remove various ceramic materials from natural teeth. Thermal effects of the laser irradiation on the dentin surfaces and pulpal tissue have been evaluated. The results indicate that the Waterlase Laser System Family is thermally safe for the expanded indications as the irradiation at the maximum power does not increase pulpal temperature to the level that would be considered unsafe. Effectiveness of the device at the lowest settings has also been demonstrated. Effectiveness of the device at the lowest settings has also been being
Clinical Testing
No clinical testing has been performed. Clinical data from published and unpublished scientific literature, further supported by the performance bench testing, demonstrate the ability of the Waterlase Laser System Family to quickly and safely remove porcelain and ceramic restorations without damaging the underlying tooth structure or overheating the surrounding tissue including pulp, and, therefore, can be used as an effective and predictable alternative to the conventional methods.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2019
Biolase, Inc. Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, CA 92618
Re: K190319
Trade/Device Name: Waterlase Laser System Family 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: February 11, 2019 Received: February 13, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190319
Device Name Waterlase Laser System Family
Indications for Use (Describe)
Waterlase laser removal of porcelain and ceramic crowns and veneers
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, 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
3
- · 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 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)
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.
4
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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: August 30, 2019
II. DEVICE
| Name of Device: | Waterlase Laser System Family |
|---|---|
| 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 Express, Biolase, Inc., K161669 Waterlase MD Turbo Plus, Biolase, Inc., K101658
DEVICE DESCRIPTION IV.
Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780mm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications.
A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, 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. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.
6
STATEMENT OF INTENDED USE V.
Waterlase Laser System Family is intended for use in oral hard and soft tissue dental applications. The Indications for Use are as follows:
Waterlase laser removal of porcelain and ceramic crowns and veneers
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, 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
- Gingivoplastv .
Biolase. Inc. Waterlase Laser System Family - 510(k) Submission
7
- 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
8
- 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. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The comparison table provided in the Substantial Equivalence section of the submission serves as the basis for the determination of substantial equivalence of the Waterlase Laser System Family to its predicate devices.
The Waterlase Laser System Family has the same intended use, the same technology and design characteristics including energy source, wavelength, laser medium, beam delivery, controls, operating principle and mechanism of action as the predicates.
VII. PERFORMANCE DATA
The results of the following testing have been used to support the submission:
Biocompatibility Testing
The biocompatibility evaluation has been performed in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The battery of testing included cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. The results demonstrate biocompatibility of the patient-contacting components of the device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing conducted for the Waterlase Laser System Family demonstrate compliance with the current revisions of the recognized standards including IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60 and IEC 60601-1-2.
Software Verification and Validation
Software verification and validation has been conducted, and documentation provided in accordance with the Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. The results demonstrate that the Waterlase Laser System Family performs according to specifications and functions intended. The software design complies with the IEC 62304 standard - Medical device software-
software life cycle processes.
9
Bench Testing
Performance bench testing has been completed to determine safety and efficacy when using a laser to remove various ceramic materials from natural teeth. Thermal effects of the laser irradiation on the dentin surfaces and pulpal tissue have been evaluated. The results indicate that the Waterlase Laser System Family is thermally safe for the expanded indications as the irradiation at the maximum power does not increase pulpal temperature to the level that would be considered unsafe. Effectiveness of the device at the lowest settings has also been demonstrated.
Effectiveness of the device at the lowest settings has also been being
Clinical Testing
No clinical testing has been performed.
Clinical data from published and unpublished scientific literature, further supported by the performance bench testing, demonstrate the ability of the Waterlase Laser System Family to quickly and safely remove porcelain and ceramic restorations without damaging the underlying tooth structure or overheating the surrounding tissue including pulp, and, therefore, can be used as an effective and predictable alternative to the conventional methods.
VIII. CONCLUSION
The Waterlase Laser System Family is substantially equivalent to its legally marketed predicate devices, Waterlase Express (K161669) and Waterlase MD Turbo Plus (K101658), in technical and design characteristics. It has the same functional and performance profile and the same intended use.
The clinical and non-clinical data, included in the submission, support the safety and efficacy of the device for the additional indication for Waterlase laser removal of porcelain and ceramic crowns and veneers.