The PerioLase Nd: YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology.

Orophayrngeal / Dental Surgery

Abscess incision and drainage
Aphthous ulcers treatment
Biopsies, incisional and excisional
Excision and ablation of benign lesions and conditions
Excision and vaporization of herpes simplex I and II
Exposure of unerupted / partially erupted teeth
Facilitation of subgingival calculus removal
Fibroma removal
Frenectomy
Frenotomy
Gingival incision and excision
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Hemostasis
Hemostatic assistance
Implant recovery
Incision of infection when used with antibiotic therapy
Laser-assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium)
Laser-assisted uvulopalatoplasty (LAUP)
Lesion (tumor) removal
Leukoplakia
Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces
Operculectomy
Oral papillectomy
Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of denture hyperplasia
Reduction of gingival hypertrophy
Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment
Removal of post-surgical granulations
Selective ablation of enamel (first degree) caries removal
Soft tissue crown lengthening
Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level or loss, and tooth mobility
Tissue retraction for impression
Vestibuloplasty

General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and glands

Appendectomy
Cholecystecomy
Debridement of decubitus ulcers
Hemorrhoidectomy
Hepatectomy
Herniorrhaphy
Lymphadenectomy
Mastectomy
Pancreatectomy
Parathyroidectomy
Partial nephrectomy
Pelvic adhesiolysis
Pilonidal cystectomy
Removal of fibromas
Removal of lesions
Removal of polyps
Removal of tumors
Resection of lipoma
Splenectomy
Thyroidectomy
Tonsillectomy
Tumor biopsy

Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

Adenoidectomy
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
Tonsillectomy

Dermatology and Plastic Surgery
Dematology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:

Debridement of decubitus ulcer
Hemangiomas
Lesions of skin and subcutaneous tissue
Periungual and subungual warts
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins
Plantar warts
Port wine lesions
Removal of tattoos
Spider veins
Telangiectasia
Treatment of keloids
Treatment of mild to moderate inflammatory acne vulgaris
Treatment of wrinkles
Venous lakes

Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including:

Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas

The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Device Description

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary. The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger. The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure. All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturer's labels.

AI/ML Overview

This document describes a 510(k) premarket notification for the PerioLase Nd:YAG Pulsed Dental Laser System. It is a submission for substantial equivalence to legally marketed predicate devices, meaning it is not a new device requiring extensive new trials but rather an expansion of indications or minor modification to an already cleared device.

Therefore, the typical acceptance criteria and study information for a de novo device are not directly reported in this document in the same way. This submission primarily relies on comparing the device to existing predicate devices and showing that it shares similar technological characteristics and has equivalent intended uses.

However, new indications for use were added, and for these, clinical and laboratory data were provided.

Here's an analysis of the provided information based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics (sensitivity, specificity, accuracy) as would be seen for a diagnostic AI device. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of:

Technological Characteristics: Wavelength, pulse energy, pulse width, repetition rate, average power, laser classification, intended use, aiming beam, output mode, laser medium, user interface, laser activation, beam delivery, soft tissue cutting method, electrical requirements, system dimensions, system weight, and cooling.
Safety and Performance Standards: Conformance to applicable regulations and safety standards, particularly 21 CFR 1010 and 21 CFR 1040 for electrical safety and output characteristics.
Indications for Use: The new indications are supported by human and animal studies, demonstrating the device's ability to perform these specific actions.

Table of Device Characteristics (excerpt from document):

Characteristic	Millennium PerioLase Nd:YAG Pulsed Dental Laser System (K182930)
Product Code	GEX, 21 CFR 878.4810
**Regulation Medical	General & Plastic Surgery
Specialty**
510(k) Review Panel	General & Plastic Surgery
Device Class	II
Laser Class	IV (4)
Wavelength	1064 nm
Aiming Beam	630-680 nm (≤ 5.0 mW)
Power (Watts)	6W maximum
Pulse Duration (µsec)	100, 150, 250, 350, 450, 550, 650
Energy per pulse (mJ)	20-300
Output Mode	Pulsed, multi-mode
Repetition Rate	10-100 Hz
Laser Medium	Flashlamp-pumped, solid-state laser rod
User Interface	Touch screen control panel
Laser Activation	Footswitch
Beam Delivery	Fiber (300, 360, 400 μm)
**Soft Tissue Cutting	Contact
Method**
**Electrical	100-240 VAC, 50/60 Hz, 8 A/4 A
Requirements**
System Dimensions	11" W x 19" D x 25" H
System Weight	45 lbs
Cooling	Air-cooled (internal water loop)

New Indications for Use and Supporting Performance (from Section 7):

Facilitation of subgingival calculus removal: Demonstrated by human and animal studies.
Modification of the dentin surface: Demonstrated by human and animal studies, including:
- Increasing the mineral and decreasing the organic composition of the dentin surface.
- Reducing bacteria on the dentin surface.
- Improving the shear bond strength of composite resin.
- Reducing the adhesive failure of composite resin.
- Removing demineralized dentin surfaces.

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

The document states: "Human and animal studies demonstrate the ability of a pulsed neodymium dental laser to remove subgingival calculus and modify the surface of dentin. The relevant clinical and laboratory reports are provided in Appendix B of this submission."

Sample Size for Test Set: Not specified in the provided document. The exact number of human subjects or animals and detailed methodology for these studies are likely contained within "Appendix B," which is not available here.
Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The nature of "clinical and laboratory reports" suggests prospective studies for the new indications, but without Appendix B, this is an inference.

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

This information is not provided in the excerpt. For laser device performance studies related to tissue manipulation, "ground truth" would typically refer to objective measurements, histological analysis, or clinical outcomes assessed by qualified dental or medical professionals, but the details are missing.

4. Adjudication Method for the Test Set

This information is not provided in the excerpt. Since the primary evidence cited for the new indications are "human and animal studies" and "laboratory reports," the concept of "adjudication method" (like 2+1 or 3+1 consensus) as typically applied to image-based AI diagnostics might not be directly applicable or detailed in this kind of submission. If expert assessment of clinical outcomes was used, an adjudication method might have been employed, but this is not stated.

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 to this device. The PerioLase Nd:YAG Pulsed Dental Laser System is a surgical laser, not an AI-powered diagnostic imaging system that assists human readers. Therefore, an MRMC study and effect size based on "human readers improve with AI vs without AI assistance" are not relevant for this device.

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

This is not applicable to this device. This is a physical laser device used by a human operator for surgical procedures, it is not an algorithm performing a task without human intervention.

7. The Type of Ground Truth Used

For the new indications (subgingival calculus removal, dentin surface modification), the ground truth would likely involve:

Histology/Pathology: For assessing changes in dentin composition, bacterial reduction, and new attachment.
Biomechanical Testing: For evaluating shear bond strength.
Clinical Outcomes/Measurements: For confirming calculus removal, or other clinical improvements observed in human and animal studies.

The document refers to "human and animal studies" and "laboratory reports" (Section 7), implying that objective measurements and assessments were used to establish the efficacy for these new indications.

8. The Sample Size for the Training Set

This is not provided and is not applicable in the context of this device. The PerioLase laser system is not an AI/ML device that requires a "training set" in the computational sense. The "training" here refers to the development and optimization of the laser parameters and techniques, which is based on general scientific understanding, preclinical testing, and potentially iterative design improvements, not a machine learning training data set.

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

This is not applicable as the device is not an AI/ML product and thus does not have a "training set" in that context.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

Millennium Dental Technologies, Inc. Robert H. Gregg President and Chairman of the Board 10945 South Street, Suite 104-A Cerritos. California 90703

July 12, 2019

Re: K182930

Trade/Device Name: PerioLase Nd: Y AG Pulsed Dental Laser System 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 6, 2019 Received: June 7, 2019

Dear Robert H. Gregg:

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.

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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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,

Neil R.P. Ogden, M.S. Acting Assistant Director, Light Based Devices Team 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

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Indications for Use

510(k) Number (if known) K182930

Device Name PerioLase Nd:YAG Pulsed Dental Laser System

Indications for Use (Describe)

Orophayrngeal / Dental Surgery

· Abscess incision and drainage
· Aphthous ulcers treatment
· Biopsies, incisional and excisional
· Excision and ablation of benign lesions and conditions
· Excision and vaporization of herpes simplex I and II
· Exposure of unerupted / partially erupted teeth
Facilitation of subgingival calculus removal
Fibroma removal
· Frenectomy
· Frenotomy
· Gingival incision and excision
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Hemostasis
· Hemostatic assistance
Implant recovery
· Incision of infection when used with antibiotic therapy
· Laser-assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium)
· Laser-assisted uvulopalatoplasty (LAUP)
· Lesion (tumor) removal
· Leukoplakia

· Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces

Operculectomy
· Oral papillectomy

· Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol

· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy
· Reduction of denture hyperplasia
· Reduction of gingival hypertrophy
Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment
· Removal of post-surgical granulations
· Selective ablation of enamel (first degree) caries removal

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· Soft tissue crown lengthening

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

· Tissue retraction for impression
· Vestibuloplasty

General Surgery

Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and glands

· Appendectomy
· Cholecystecomy
Debridement of decubitus ulcers
· Hemorrhoidectomy
· Hepatectomy
· Herniorrhaphy
Lymphadenectomy
· Mastectomy
· Pancreatectomy
· Parathyroidectomy
· Partial nephrectomy
· Pelvic adhesiolysis
· Pilonidal cystectomy
· Removal of fibromas
· Removal of lesions
· Removal of polyps
Removal of tumors
· Resection of lipoma
· Splenectomy
· Thyroidectomy
· Tonsillectomy
· Tumor biopsy

Endonasal Surgery

Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

· Adenoidectomy
· Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
Tonsillectomy

Dermatology and Plastic Surgery

Dematology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:

Debridement of decubitus ulcer
· Hemangiomas
· Lesions of skin and subcutaneous tissue
· Periungual and subungual warts

· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins

· Plantar warts
· Port wine lesions
· Removal of tattoos
Spider veins
· Telangiectasia
Treatment of keloids

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· Treatment of mild to moderate inflammatory acne vulgaris
Treatment of wrinkles
Venous lakes

Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including:

Matrixectomy
· Periungual and subungual warts
Plantar warts
· Radical nail excision
· Neuromas

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)

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Image /page/5/Picture/0 description: The image shows the logo for Millennium Dental Technologies, Inc. The logo consists of a red graphic on the left, followed by the company name in blue. A blue line is present at the bottom of the logo.

510(k) Summary

Submitter: Millennium Dental Technologies, Inc. 10945 South Street Suite 306 Cerritos. California 90703 Telephone: (562) 860-2908 Fax: (562) 860-2429 Contact Person: Robert H. Gregg II, DDS, President Mobile: (562) 577-2454 Date Prepared: July 12, 2019

1. Device Name:

Trade Name:	PerioLase Nd:YAG Pulsed Dental Laser System
Common Name:	Nd:YAG Pulsed Dental Laser
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Classification Regulation:	21 CFR 878.4810
Classification Panel:	General and Plastic Surgery
Device Class:	Class II
Product Code:	GEX

2. Legally Marketed Predicate Devices:

PerioLase, Millennium Dental Technologies, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Research, K011960 Dentica, Xintec, K971065

3. Device Description:

PerioLase Nd:YAG Pulsed Dental Laser System (same as K010771, K014272, K030290, and K151763)

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microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adiustments are made if necessary.

The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger.

The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure.

All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturer's labels.

Wavelength	1.064 microns (1064 nm)
Pulse Energy	20 to 300 mJ
Pulse Width	100 µsec to 650 µsec
Repetition Rate	10 to 100 Hz
Average Power	6 Watts maximum
Laser Classification	Class IV

4. Intended Uses:

The PerioLase Nd:YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology. It is indicated for the following indications for use:

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Oropharyngeal / Dental Surgery

Abscess incision and drainage .
. Aphthous ulcers treatment
Biopsies, incisional and excisional ●
Excision and ablation of benign lesions and conditions .
Excision and vaporization of herpes simplex I and II ●
Exposure of unerupted / partially erupted teeth
. Facilitation of subgingival calculus removal
Fibroma removal
Frenectomy
Frenotomy ●
Gingival incision and excision ●
Gingival troughing for crown impressions ●
Gingivectomy
Gingivoplasty
Hemostasis ●
Hemostatic assistance
Implant recovery ●
Incision of infection when used with antibiotic therapy ●
Laser-assisted new attachment procedure (cementum-mediated periodontal . ligament new-attachment to the root surface in the absence of long junctional epithelium)
Laser-assisted uvulopalatoplasty (LAUP) .
Lesion (tumor) removal
Leukoplakia .
Modification of the dentin surface, including increasing the mineral and ● decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces
Operculectomy
. Oral Papillectomy
Periodontal regeneration true regeneration of the attachment apparatus . (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
Pulpotomy
Pulpotomy as an adjunct to root canal therapy .
Reduction of denture hyperplasia
Reduction of gingival hypertrophy ●
Removal of filling material such as qutta-percha or resin as adiunct treatment ● during root canal retreatment
Removal of post-surgical granulations
Selective ablation of enamel (first degree) caries removal ●
Soft tissue crown lengthening ●
Sulcular debridement or soft tissue curettage (removal of diseased or . inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level or loss, and tooth mobility

{8}------------------------------------------------

Tissue retraction for impression ●
Vestibuloplasty .

General Surgery

Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

. Appendectomy
Cholecystectomy .
Debridement of decubitus ulcers ●
Hemorrhoidectomy ●
Hepatectomy
Herniorrhaphy ●
Lymphadenectomy ●
Mastectomy ●
Pancreatectomy ●
Parathyroidectomy
Partial nephrectomy ●
Pelvic adhesiolysis
Pilonidal cystectomy ●
. Removal of fibromas
Removal of Iesions .
Removal of polyps ●
Removal of tumors ●
Resection of lipoma ●
Splenectomy
Thyroidectomy ●
Tonsillectomy ●
Tumor biopsy .

Endonasal Surgerv

Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

Adenoidectomy
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal ● tissues
. Tonsillectomy

Dermatology and Plastic Surgery

Dermatology and plastic surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

Debridement of decubitus ulcer ●
Hemangiomas ●
Lesions of skin and subcutaneous tissue .
Periungual and subungual warts
Photocoagulation and hemostasis of pigmented and vascular lesions, such ● as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins

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Plantar warts ●
Port wine lesions ●
Removal of tattoos ●
Spider veins
Telangiectasia .
. Treatment of keloids
Treatment of mild to moderate inflammatory acne vulgaris .
Treatment of wrinkles ●
Venous lakes .

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

. Matrixectomy
Periungual and subungual warts ●
Plantar warts ●
Radical nail excision .
. Neuromas

5. Summary of a Comparison of Technological Characteristics:

The comparison table below establishes the basis for the determination of substantial equivalence of the PerioLase Nd:YAG Pulsed Dental Laser System to its named predicate devices.

This submission consolidates soft tissue surgical indications for use of substantially equivalent devices.

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Characteristic	MillenniumPerioLase	MillenniumPerioLaseK1517633/15/16	PinPointe USAPinPointe FootLaserK09354710/15/10	FotonaLightWalker Nd:YAGK12150812/12/12	Lares ResearchSunLase 800 P(PocketPro)K01196012/21/01	XintecDenticaK9710656/17/97
Product Code	General & Plastic Surgeryand Dermatology	General & Plastic Surgeryand Dermatology	General & Plastic Surgeryand Dermatology	General & Plastic Surgeryand Dermatology	General & Plastic Surgeryand Dermatology	General & Plastic Surgeryand Dermatology
Regulation	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810
Regulation MedicalSpecialty	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery
510(k) Review Panel	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery	General & Plastic Surgery
Device Class	II	II	II	II	II	II
Laser Class	IV (4)	IV (4)	IV (4)	IV (4)	IV (4)	IV (4)
Intended Use	Intended for use in lasersurgery procedures forablating, incising, excising,vaporizing, andcoagulating soft tissues inspecialties such as generaland cosmetic dentistry,including tooth whitening,modification of dentinsurface, temporary reliefof pain, oral,maxillofacial, andcosmetic surgery,otolaryngology / ENTsurgery, arthroscopy,dermatology and plasticsurgery, gastroenterology,general surgery,gynecology, neurosurgery,ophthalmology, podiatry,pulmonary surgery, andurology	Intended for ablating,incising, excising,vaporization andcoagulation of soft tissuesusing a contact fiber-opticdelivery system. Thedevice will be used in thefollowing areas: generaland cosmetic dentistry,otolaryngology,arthroscopy,gastroenterology, generalsurgery, dermatology &plastic surgery,neurosurgery, gynecology,urology, ophthalmology,& pulmonary generalsurgery	Intended for use ingeneral and cosmeticdentistry,otolaryngology/ENTsurgery, dermatology andplastic surgery, oralmaxillofacial and cosmeticsurgery, and podiatry	Intended for use indentistry, dermatology,general surgery, andpodiatry	Indicated for ablating,incising, excising,vaporization, andcoagulation of softtissues. The device will beused in general andcosmetic dentistry,otolaryngology,dermatology, and plasticsurgery.	Indicated forincision/excision, ablationand coagulation(homeostasis) of softtissue and cartilage.Specific surgicalspecialties includedentistry, oral surgery, ear,nose & throat (ENT), headand neck surgery, thoracicsurgery, neurology(homeostasis only),dermatology, plasticsurgery, general surgery
Wavelength	1064 nm	1064 nm	1064 nm	1064 nm	1064 nm	1064 nm
Aiming Beam	630-680 nm (≤ 5.0 mW)	660 nm (1 mW)	630-680 nm (< 2.5 mW)	650 nm (≤ 1 mW)	633 nm (1 mW)	632.8 nm (5 mW)
Power Watts	6W	6W	6W, 30W, 100W	8 W	8 W	15 W
Pulse Duration(µsec)	100, 150, 250, 350, 450,550, 650	100, 150, 250, 350, 450,550, 650	100-700 (6W), 350-3000(30W), 350-3000 (100W)	100, 180, 650	110, 280	100, 160, 300, 500, 700
Energy per pulse(mJ)	20-300	20-300	20-200 (6W), 20-1000(30W), 20-3500 (100W)	≤ 10,000 mJ	30 to 400	100 to 200
Output Mode	Pulsed, multi-mode	Pulsed, multi-mode	Pulsed, multi-mode	Pulsed	Pulsed	Pulsed
Repetition Rate	10-100 Hz	10-100 Hz	5-100 Hz	10-100 Hz	10-50 Hz	10-30 Hz
Characteristic	MillenniumPerioLase	MillenniumPerioLaseK1517633/15/16	PinPointe USAPinPointe FootLaserK09354710/15/10	FotonaLightWalker Nd:YAGK12150812/12/12	Lares ResearchSunLase 800 P(PocketPro)K01196012/21/01	XintecDenticaK9710656/17/97
Laser Medium	Flashlamp-pumped, solid-state laser rod	Flashlamp-pumped, solidstate laser rod	Flashlamp-pumped, solidstate laser rod	Flashlamp-pumped solidstate rod	Flashlamp-pumped solidstate rod	Flashlamp-pumped solidstate rod
User Interface	Touch screen controlpanel	Touch screen controlpanel	Push-button control panel	Touch screen control	Touch screen control	Touch screen control
Laser Activation	Footswitch	Footswitch	Footswitch	Footswitch	Footswitch	Footswitch
Beam Delivery	Fiber300, 360, 400 μm	Fiber200, 320, 400, 600 μm	Fiber200 to 1000 μm	Fiber320 μm	Fiber200, 320 μm	Fiber300, 320, 400, 600 μm
Soft Tissue CuttingMethod	Contact	Contact	Contact	Contact	Contact	Contact
ElectricalRequirements	100-240 VAC, 50/60 Hz, 8A/4 A	120 VAC, 10 A or 220 VAC,5 A, 50/60 Hz	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz	230 VAC, 10 A, 50/60 Hz	120 VAC, 10 A, 50/60 Hz220 VAC, 5 A, 50/60 Hz	120 VAC, 20 A, 60 Hz
System Dimensions	11" W x 19" D x 25" H	11" W x 16.5" D x 28" H	13" W x 14" D x 32" H	11.4" W x 21.6" D x 32.2"H	10" W x 18" D x 31" H	10" W x 22" D x 36" H
System Weight	45 lbs	45 lbs	38 lbs	130 lbs	110 lbs	150 lbs
Cooling	Air-cooled (internal waterloop)	Air-cooled (internal waterloop)	Air-cooled (internal waterloop)	Air-cooled (internal waterloop)	Air-cooled (internal waterloop)	Air-cooled (internal waterloop)
Characteristic	MillenniumPerioLase	MillenniumPerioLaseK1517633/15/16	PinPointe USAPinPointe FootLaserK09354710/15/10	FotonaLightWalker Nd:YAGK12150812/12/12	Lares ResearchSunLase 800 P(PocketPro)K01196012/21/01	XintecDenticaK9710656/17/97
Indications for UseStatement	Intended Uses of the Device:The PerioLase Nd:YAG PulsedDental Laser System is intendedfor use in laser surgeryprocedures for ablation, incision,excision, vaporization, andcoagulation of soft tissues inspecialties such as general andcosmetic dentistry, oral,maxillofacial, and cosmeticsurgery, otolaryngology / ENTsurgery, arthroscopy,dermatology and plastic surgery,gastroenterology, generalsurgery, gynecology,neurosurgery, ophthalmology,podiatry, pulmonary surgery,and urology.	Intended Uses of the Device:The PerioLase Nd:YAG PulsedDental Laser System is to providethe ability to perform intraoralsoft tissue dental, general, oralmaxillofacial, and cosmeticsurgery. The PerioLase isintended for ablating, incising,excising, vaporization andcoagulation of soft tissues usinga contact fiber-optic deliverysystem. The device will be usedin the following areas: generaland cosmetic dentistry,otolaryngology, arthroscopy,gastroenterology, generalsurgery, dermatology & plasticsurgery, neurosurgery,gynecology, urology,ophthalmology, and pulmonarygeneral surgery.	The PinPointeTM FootLaserTM andthe delivery accessories that areused with them are intended foruse in surgical proceduresinvolving open, laparoscopic andendoscopic ablation,vaporization, excision, incision,and coagulation of soft tissue inthe medical specialties ofgeneral and cosmetic dentistry,otolaryngology / ENT surgery,and dermatology & plasticsurgery including intraoral softtissue dental surgery, oralmaxillofacial and cosmeticsurgery, general surgery, E.N.T.surgery, podiatry, anddermatology and plastic surgery.	Intended for use in dentistry,dermatology, and other surgicalareas.	Performs intraoral soft tissuedental, general, oral maxillo-facial and cosmetic surgery.Intended for use in general andcosmetic dentistry,otolaryngology, dermatology,and plastic surgery.	Indicated for incision/excision,ablation, and coagulation(homeostasis) of soft tissue andcartilage. Soft tissue which maybe encountered in surgicalprocedure includes skin,subcutaneous tissue, striatedand smooth muscle, cartilage,mucous membrane, lymphvessels and nodes, organs andglands. Specific surgicalspecialties include dentistry, oralsurgery, ear nose and throat(ENT), head and neck surgery,thoracic surgery, neurology(homeostasis only),dermatology, plastic surgery,general surgery.
Oropharyngeal /Dental SurgeryIndications for Use	Oropharyngeal / Dental Surgery• Abscess incision and drainage• Aphthous ulcers treatment• Biopsies, incisional andexcisional• Excision and ablation ofbenign lesions and conditions• Excision and vaporization ofherpes simplex I and II• Exposure of unerupted /partially erupted teeth• Facilitation of subgingivalcalculus removal• Fibroma removal• Frenectomy• Frenotomy• Gingival incision and excision• Gingival troughing for crownimpressions• Gingivectomy• Gingivoplasty• Hemostasis• Hemostatic assistance• Implant recovery• Incision of infection whenused with antibiotic therapy• Laser-assisted newattachment procedure(cementum-mediatedperiodontal ligament new-	Intended use:The following are theoropharyngeal indications foruse for which the device will bemarketed:• Abscess Incision and Drainage• Aphthous ulcers treatment• Biopsies excision and incision• Crown lengthening• Hemostatic assistance• Fibroma removal• Frenectomy• Frenotomy• Gingival Incision and Excision• Gingivectomy• Gingivoplasty• Operculectomy• Oral Papillectomy• Tissue retraction forimpression• Vestibuloplasty• Selective ablation of enamel(first degree) caries• Exposure of unerupted /partially erupted teeth• Implant recovery• Lesion (tumor) removal• Leukoplakia• Pulpotomy• Pulpotomy as adjunct to root	Oropharyngeal / Dental SurgeryIndicated for:• Abscess incision and drainage• Aphthous ulcers treatment• Biopsies, excisional andincisional• Crown lengthening• Exposure of unerupted /partially erupted teeth• Fibroma removal• Frenectomy• Frenotomy• Gingival incision and excision• Gingivectomy• Gingivoplasty• Hemostasis• Implant recovery• Lesion (tumor) removal• Leukoplakia• Operculectomy• Oral papillectomy• Pulpotomy• Pulpotomy as adjunct to rootcanal therapy• Removal of filling materialsuch as gutta-percha or resinas adjunct treatment duringroot canal re-treatment• Selective ablation of enamel(first degree) caries removal	Nd:YAG laser (1064 nmwavelength) in dentistry:• Excisional and incisionalbiopsies• Excision and vaporization ofherpes simplex I and II• Exposure of unerupted teeth• Fibroma removal• Frenectomy and frenotomy• Gingival troughing for crownimpressions• Gingivectomy• Gingivoplasty• Gingival incision and excision• Hemostasis• Implant recovery• Incision and drainage ofabscess• Laser assisteduvulopalatoplasty (LAUP)• Operculectomy• Oral papillectomies• Pulpotomy and pulpotomy asan adjunct to root canaltherapy• Reduction of denturehyperplasia• Reduction of gingivalhypertrophy• Removal of filling material	The SunLase 800P laser device isto provide the ability to performintraoral soft tissue dental,general, oral maxillofacial, andcosmetic surgery. The device isindicated for ablating, incising,excising, vaporization, andcoagulation of soft tissues usinga contact, fiber-optic deliverysystem. The device will be usedin the following area: generaland cosmetic dentistry,otolaryngology, dermatology,and plastic surgery. Thefollowing are the oropharyngealindications for use for which thedevice will be marketed:• Excisional and incisionalbiopsies• Excision and vaporization ofherpes simplex I and II• Exposure of unerupted teeth• Fibroma removal• Frenectomy and frenotomy• Gingival troughing for crownimpressions• Gingivectomy• Gingivoplasty• Gingival incision and excision• Hemostasis• Implant recovery	Dentistry:• Gingivectomy• Gingivoplasty• Incision and excision• Laser curettageOral Surgery:• Crown lengthening• Excision and ablation ofbenign and malignant lesionsand conditions• Frenectomy• Hemostasis• Incisional and excisionalaphthous ulcers• Incisional and excisionalbiopsy• Incision of infection whenused with antibiotic therapy• Operculectomy
Characteristic	Millennium	Millennium	PinPointe USA	Fotona	Lares Research	Xintec
	PerioLase	PerioLase	PinPointe FootLaser	LightWalker Nd:YAG	SunLase 800 P	Dentica
		K151763	K093547	K121508	(PocketPro)	K971065
		3/15/16	10/15/10	12/12/12	K011960	6/17/97
					12/21/01
	attachment to the root	canal therapy	• Sulcular debridement	such as gutta-percha or resin	• Incision and drainage of
	surface in the absence of longjunctional epithelium)	• Removal of filling materialsuch as gutta-percha or resin	(removal of diseased orinflamed soft tissue in the	as adjunct treatment duringroot canal therapy	abscess
	• Laser-assisted	as adjunct treatment during	periodontal pocket) to	• Removal of post-surgical	• Laser assisted
	uvulopalatoplasty (LAUP)	root canal retreatment	improve clinical indices	granulations	uvulopalatoplasty (LAUP) –
	• Lesion (tumor) removal	• Sulcular debridement	including gingival index,	• Soft tissue crown lengthening	This laser is effective for
	• Leukoplakia	(removal of diseased or	gingival bleeding index, probe	• Sulcular debridement or soft	cutting, ablating, coagulating,
	• Modification of the dentin	inflamed soft tissue in the	depth, attachment loss, and	tissue curettage (removal of	and removing oropharyngeal
	surface, including increasing	periodontal pocket) to	tooth mobility	diseased or inflamed soft	soft tissue that has been
	the mineral and decreasingthe organic composition of	improve clinical indicesincluding gingival index,	• Tissue retraction forimpressions	tissue in the periodontalpocket to improve clinical	diagnosed as anatomically
	the dentin surface, reducing	gingival bleeding index, probe	• Vestibuloplasty	indices including gingival	abnormal or naturally
	bacteria on the dentin	depth, attachment level and		index, gingival bleeding index,	occurring hypertrophic which
	surface, improving the shear	tooth mobility		probe depth, attachment	has been identified and
	bond strength of composite	• Laser-assisted new		loss, and tooth mobility)	confirmed as being
	resin, reducing the adhesive	attachment procedure		• Tissue retraction for	associated with chronic
	failure of composite resin,and removing demineralized	(cementum-mediatedperiodontal ligament new-		impression	palatal snoring.
	dentin surfaces	attachment to the root		• Treatment of aphthous ulcers	• Leukoplakia
	• Operculectomy	surface in the absence of long		• Vestibuloplasty	• Operculectomy
	• Oral Papillectomy	junctional epithelium)			• Oral papillectomies
	• Periodontal regeneration –	• Periodontal regeneration -			• Pulpotomy and pulpotomy as
	true regeneration of the	true regeneration of the			an adjunct to root canal
	attachment apparatus (new	attachment apparatus (newcementum, new periodontal			therapy
	cementum, new periodontalligament, and new alveolar	ligament, and new alveolar			• Reduction of denture
	bone) on a previously	bone) on a previously			hyperplasia
	diseased root surface when	diseased root surface when			• Reduction of gingival
	used specifically in the	used specifically in the			hypertrophy
	LANAP® Protocol	LANAP® Protocol			• Removal of filling material
	• Pulpotomy				such as gutta-percha or resin
	• Pulpotomy as an adjunct toroot canal therapy				as adjunct treatment during
	• Reduction of denture				root canal therapy
	hyperplasia				• Removal of post-surgical
	• Reduction of gingival				granulations
	hypertrophy				• Selective ablation of enamel
	• Removal of filling material				(first degree caries removal)
	such as gutta-percha or resinas an adjunct treatment				• Soft tissue crown lengthening
	during root canal retreatment				• Sulcular debridement or soft
	• Removal of post-surgical				tissue curettage (removal of
	granulations				diseased or inflamed soft
	• Selective ablation of enamel				tissue in the periodontal
	(first degree) caries removal				pocket) to improve clinical
	• Soft tissue crown lengthening				indices including gingival
	• Sulcular debridement or soft				index, gingival bleeding index,
	tissue curettage (removal ofdiseased or inflamed soft				probe depth, attachment
	tissue in the periodontal				loss, and tooth mobility)
	pocket) to improve clinical				• Tissue retraction for
	indices including gingival				impression
	index, gingival bleeding index,				• Treatment of aphthous ulcers
	probe depth, attachment				• Vestibuloplasty
Characteristic	MillenniumPerioLase	MillenniumPerioLaseK1517633/15/16	PinPointe USAPinPointe FootLaserK09354710/15/10	FotonaLightWalker Nd:YAGK12150812/12/12	Lares ReseaSunLase 800(PocketPro)K01196012/21/01
General SurgeryIndications for Use	level or loss, and toothmobility• Tissue retraction forimpression• Vestibuloplasty
	General SurgeryOpen, laparoscopic, andendoscopic general surgery(ablation, vaporization, incision,excision, and coagulation of softtissue). All soft tissue isincluded, striated and smoothtissue, muscle, cartilage,meniscus, mucous membrane,lymph vessels and nodes, organsand glands		General Surgery Indicated for:Open, laparoscopic, andendoscopic general surgery(ablation, vaporization, incision,excision, and coagulation of softtissue) including:	General surgery indications:surgical incision, excision,vaporization, and coagulation ofsoft tissue. All soft tissue isincluded, striated and smoothtissue, muscle, cartilage,meniscus, mucous membrane,lymph vessels and nodes, organsand glands, fibroma removal.
	• Appendectomy• Cholecystectomy• Debridement of decubitusulcer• Hemorrhoidectomy• Hepatectomy• Herniorrhaphy• Lymphadenectomy• Mastectomy• Pancreatectomy• Parathyroidectomy• Partial nephrectomy• Pelvic adhesiolysis• Pilonidal cystectomy• Removal of fibromas• Removal of lesions• Removal of polyps• Removal of tumors• Resection of lipoma• Splenectomy• Thyroidectomy• Tonsillectomy• Tumor biopsy		• Cholecystectomy• Lymphadenectomy• Mastectomy• Partial nephrectomy• Hepatectomy• Pilonidal cystectomy• Pancreatectomy• Resection of lipoma• Splenectomy• Pelvic adhesiolysis• Hemorrhoidectomy• Removal of lesions• Thyroidectomy• Removal of polyps• Parathyroidectomy• Removal of tumors• Herniorrhaphy• Tumor biopsy• Tonsillectomy• Debridement of decubitusulcers• Appendectomy
	Endonasal SurgeryIndications for Use	Endonasal SurgeryEndonasal surgery (ablation,vaporization, incision, excision,and coagulation of soft tissue)including:		Endonasal SurgeryEndonasal surgery (ablation,vaporization, incision, excision,and coagulation of soft tissue)including:
		• Adenoidectomy• Lesions or tumors of the oral,nasal, glossal, pharyngeal andlaryngeal tissues• Tonsillectomy		• Lesions or tumors of the oral,nasal, glossal, pharyngeal &laryngeal tissues• Tonsillectomy• Adenoidectomy
		Dermatology andPlastic SurgeryIndications for Use	Dermatology and Plastic SurgeryDermatology and plastic surgery(ablation, vaporization, incision,excision, and coagulation of softtissue)		Dermatology and Plastic SurgeryDermatology and plastic surgery(ablation, vaporization, incision,excision, and coagulation of softtissue) including:

Summary of a Comparison of Technological Characteristics

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Summary of a Comparison of Indications for Use

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arch00 P)	XintecDenticaK9710656/17/97
	General Surgery Head and Neck Surgery Thoracic Surgery
		Ear Nose & Throat (ENT)	Dermatology Plastic Surgery

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Characteristic	MillenniumPerioLase	MillenniumPerioLaseK1517633/15/16	PinPointe USAPinPointe FootLaserK09354710/15/10	FotonaLightWalker Nd:YAGK12150812/12/12	Lares ResearchSunLase 800 P(PocketPro)K01196012/21/01	XintecDenticaK9710656/17/97
		Debridement of decubitusulcer Hemangiomas Lesions of skin andsubcutaneous tissue Periungual and subungualwarts Photocoagulation andhemostasis of pigmented andvascular lesions, such as, butnot limited to, port winestains, hemangiomae, warts,telangiectasiae, rosacea,venous lake, leg veins, andspider veins Plantar warts Port wine lesions Removal of tattoos Spider veins Telangiectasia Treatment of keloids Treatment of mild tomoderate inflammatory acnevulgaris Treatment of wrinkles Venous lakes	Lesions of skin andsubcutaneous tissue Telangiectasia Port wine lesions Spider veins Hemangiomas Plantar warts Periungual and subungualwarts Removal of tattoos Debridement of decubitusulcer Treatment of keloids	permanent hair reductionand for treatment of PFB.The laser is indicated for allskin types, Fitzpatrick I-VI,including tanned skin.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime. Photocoagulation andhemostasis of pigmented andvascular lesions, such as, butnot limited to, port winestains, hemaongiomae, warts,telangiectasiae, rosacea,venous lake, leg veins andspider veins Treatment of wrinkles Treatment of mild tomoderate inflammatory acnevulgaris
Podiatry	Podiatry (ablation, vaporization,incision, excision, andcoagulation of soft tissue)including: Matrixectomy Periungual and subungualwarts Plantar warts Radical nail excision Neuromas The PerioLase® MVP-7™ isindicated for use for thetemporary increase of clear nailin patients with onychomycosis(e.g., dermatophytesTrichophyton rubrum and T.mentagrophytes, and/or yeastsCandida albicans, etc.).		Podiatry (ablation, vaporization,incision, excision, andcoagulation of soft tissue)including: Matrixectomy Periungual and subungualwarts Plantar warts Radical nail excision Neuromas The PinPointe™ FootLaser™ isindicated for use for thetemporary increase of clear nailin patients with onychomycosis(e.g., dermatophytesTrichophyton rubrum and T.mentagrophytes, and/or yeastsCandida albicans, etc.).	Podiatry (ablation, vaporization,incision, excision, andcoagulation of soft tissue)including: Matrixectomy Periungual and subungualwarts Plantar warts Radical nail excision Neuromas The Fotona LightWalker LaserSystem Family is indicated foruse for the temporary increaseof clear nail in patients withonychomycosis (e.g.,dermatophytes Trichophytonrubrum and T. mentagrophytes,and/or yeasts Candida albicans,etc.).

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The PerioLase MVP-7 has the following technological similarities to the named predicate devices:

Same product code and regulation: GEX, 21 CFR 878.4810
Equivalent user interface ●
Same laser activation method: footswitch ●
Same output mode: pulsed ●
Equivalent delivery system: optical fiber ●
Equivalent patient contacting component: fiber tip ●
Same soft tissue cutting methods: tissue contact .
Equivalent mechanism of action: light converted to heat .

The PerioLase MVP-7 is a free-running Nd:YAG solid-state laser based on the same technology as the predicate Nd:YAG lasers. The specific user interfaces and displays (control panel) differ among the devices, but these differences are considered minor since the panels control the same types of operational parameters on their respective devices. The PerioLase Nd:YAG Pulsed Dental Laser System includes a built-in power meter for additional functionality which enables the user to confirm the power being emitted at the optical fiber tip with the power being displayed on the touch screen. Hence, the intended use and indications for use on soft tissue are the same as or equivalent to the predicate devices. This consolidation of clinical applications presents no new issues.

6. Nonclinical Performance Data:

The PerioLase Nd:YAG Pulsed Dental Laser System has been evaluated via verification and validation tests and inspections for conformance to applicable regulations and safety standards. Each PerioLase is tested for electrical safety and output characteristics to ensure it meets the design criteria for essential performance, its safety features and functions operate correctly, and it satisfies the performance requirements specified in 21 CFR 1010 and 21 CFR 1040. Representative data is presented in the Performance section and Appendix C of the previous PerioLase submission K151763.

7. Clinical and Laboratory Performance Data:

Human and animal studies demonstrate the ability of a pulsed neodymium dental laser to remove subgingiyal calculus and modify the surface of dentin. The relevant clinical and laboratory reports are provided in Appendix B of this submission. Based on these reports, the following new indications for use are added:

Facilitation of subqinqival calculus removal
Modification of the dentin surface, including increasing the mineral and ● decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin. reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces

8. Conclusions:

The PerioLase Nd:YAG Pulsed Dental Laser System is substantially equivalent to the predicate devices in functional and performance characteristics, and for the intended uses in the stated medical specialties. The PerioLase is designed to comply with applicable federal and international safety and performance standards.

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.