Waterlase Express by Biolase, Inc.

· 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.

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.

AI/ML Overview

Note: The provided document is a 510(k) summary for a medical device (Waterlase Express). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML diagnostic. Therefore, some of the requested information (e.g., sample sizes for training sets, number of experts for ground truth in AI/ML studies, MRMC studies) is not applicable or not present in this regulatory document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable form often seen in AI/ML device submissions. Instead, the substantial equivalence is demonstrated by showing that the new device (Waterlase Express) performs "as well as" or "equivalent to" the predicate device (Waterlase MD Turbo Plus) based on various performance data. For a direct comparison, the table below will summarize the technological characteristics and the performance statements made.

Category	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Waterlase Express)
Biocompatibility	Must comply with ISO 10993-1 as recognized by FDA.	Conducted in accordance with ISO 10993-1. Results demonstrate biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity).
Electrical Safety & EMC	Must meet recognized standards: IEC 60601-1-2 (EMC), IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60 (Safety).	Device meets applicable requirements related to the above-referenced standards.
Software V&V	Must perform according to specifications and intended functions, following FDA guidance for software in medical devices and cybersecurity.	Verification and validation testing performed. Results demonstrate Waterlase Express performs according to specifications and functions intended.
Bench Testing (Performance)	Must perform "as well as" the predicate device (Waterlase MD Turbo Plus) in-vitro on soft and hard tissue for its stated indications.	In-vitro testing conducted on soft and hard tissue. Results demonstrate Waterlase Express performs "as well as" the predicate device, Waterlase MD Turbo Plus, for the same indications for use. Note: The document does not provide specific quantitative metrics of "performance" for the in-vitro testing.
Indications for Use	Must have the same indications for use as the predicate device.	Waterlase Express has identical indications for use as the Waterlase MD Turbo Plus.
Safety and Effectiveness	Must be as safe and effective as the predicate device.	Conclusion states Waterlase Express is as safe and effective as the predicate device based on technical characteristics, operating principle, mechanism of action, same indications, and equivalent performance.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size:
- For biocompatibility testing, electrical safety, EMC, and software V&V, the "sample size" refers to the device units tested or the software code, not patient data. The document does not specify the number of devices or software modules tested.
- For bench testing, the document states "In-vitro testing was conducted on soft and hard tissue." No specific number of tissue samples (i.e., test set sample size) is provided.
- Clinical testing was not performed for this device as the indications for use are the same as the predicate and performance characteristics are deemed equivalent based on bench testing. Thus, there is no human "test set" in the context of clinical performance.
Data Provenance: Not applicable for a device that relies on bench testing and substantial equivalence. The "data" comes from laboratory and engineering tests of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable. Since no clinical testing or AI/ML components requiring human expert ground truth for classification/diagnosis are detailed, no experts were used in this manner. The "ground truth" for the device's functionality and safety is established by adherence to recognized standards and comparative bench testing against a well-established predicate.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. There was no clinical study with human readers/interpreters that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The Waterlase Express is a surgical laser device, not an AI/ML diagnostic or assistive tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The Waterlase Express is a medical device, not an algorithm, and it is used by a human operator (dentist/surgeon).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the technical and performance aspects:
- Biocompatibility: Ground truth is established by adherence to ISO 10993-1.
- Electrical Safety & EMC: Ground truth is established by adherence to recognized IEC standards.
- Software V&V: Ground truth is established by the device's specifications and FDA guidance.
- Bench Testing: The "ground truth" for performance is the demonstrated performance of the predicate device (Waterlase MD Turbo Plus) when tested under comparable in-vitro conditions. The studies aim to show the subject device performs effectively in the same way the predicate device does on hard and soft tissues.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML system, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable. As there is no AI/ML component or "training set," no ground truth was established for this purpose.

Summary

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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

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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

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· 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.

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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.

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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.

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	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 / UserInterface	Tablet PC	LCD Touchscreen
Footswitch	Wireless	Wired
Indications for Use	General Hard Tissue Indications(for use in adult and pediatricpatients)• Class I, II, III, IV and V cavitypreparation• Caries removal• Hard tissue surface roughening oretching• Enameloplasty, excavation of pitsand fissures for placement ofsealants	General Hard Tissue Indications(for use in adult and pediatricpatients)• Class I, II, III, IV and V cavitypreparation• Caries removal• Hard tissue surface roughening oretching• Enameloplasty, excavation of pitsand fissures for placement ofsealants

Table 1: Comparison of Waterlase Express to Waterlase MD Turbo Plus

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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

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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.

Regulation Number and Section

§ 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.