Predicate Devices

K151763, K093547, K121508, K011960, K971065

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the hardware components, control systems (microcontroller, watchdog microprocessor), and safety features of a pulsed dental laser system. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities based on data. The control system appears to be based on pre-programmed logic and feedback loops for maintaining output parameters.

Therapeutic

Yes

Explanation: The device is clearly indicated for various medical and surgical procedures across numerous specialties, including ablation, incision, excision, vaporization, and coagulation of soft tissues, as well as specific treatments like the LANAP Protocol for periodontal regeneration and temporary increase of clear nails in onychomycosis. These applications are inherently therapeutic, aiming to treat or alleviate diseases, injuries, or conditions.

Diagnostic

No

This device is a surgical laser system used for ablation, incision, excision, vaporization, and coagulation of soft tissues, as well as for specific therapeutic procedures like treating onychomycosis. Its intended uses are interventional and therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components including a laser head, flashlamp, fiber-optic cable, cooling system, and touch screen display, indicating it is a hardware device with integrated software control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as a surgical laser system for performing procedures on living soft tissues within the body. This is an in-vivo application.
Device Description: The description details the components and function of a laser system designed for delivering energy to tissue.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment.

IVD devices are used to perform tests on samples taken from the body, while this device is used to directly treat or modify tissues within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.).

Product codes

GEX

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 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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. Specific mentions include: Oropharyngeal / Dental, General Surgery (all soft tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands), Endonasal (oral, nasal, glossal, pharyngeal and laryngeal tissues), Dermatology and Plastic Surgery (skin and subcutaneous tissue), Podiatry (nail, periungual and subungual warts, plantar warts).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The 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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151763, K093547, K121508, K011960, K971065

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K182930

Device Name PerioLase Nd:YAG Pulsed Dental Laser System

Indications for Use (Describe)

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, podiaty, 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

3

· 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

4

· 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.).

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.

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5

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 plastic
surgery 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)

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

6

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:

7

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

9

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

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.).

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.

10

| Characteristic | Millennium
PerioLase | Millennium
PerioLase
K151763
3/15/16 | PinPointe USA
PinPointe FootLaser
K093547
10/15/10 | Fotona
LightWalker Nd:YAG
K121508
12/12/12 | Lares Research
SunLase 800 P
(PocketPro)
K011960
12/21/01 | Xintec
Dentica
K971065
6/17/97 |
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| Product Code | General & Plastic Surgery
and Dermatology | General & Plastic Surgery
and Dermatology | General & Plastic Surgery
and Dermatology | General & Plastic Surgery
and Dermatology | General & Plastic Surgery
and Dermatology | General & Plastic Surgery
and 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 Medical
Specialty | 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 laser
surgery procedures for
ablating, incising, excising,
vaporizing, and
coagulating soft tissues in
specialties such as general
and cosmetic dentistry,
including tooth whitening,
modification of dentin
surface, temporary relief
of pain, oral,
maxillofacial, and
cosmetic surgery,
otolaryngology / ENT
surgery, arthroscopy,
dermatology and plastic
surgery, gastroenterology,
general surgery,
gynecology, neurosurgery,
ophthalmology, podiatry,
pulmonary surgery, and
urology | Intended for ablating,
incising, excising,
vaporization and
coagulation of soft tissues
using a contact fiber-optic
delivery system. The
device will be used in the
following areas: general
and cosmetic dentistry,
otolaryngology,
arthroscopy,
gastroenterology, general
surgery, dermatology &
plastic surgery,
neurosurgery, gynecology,
urology, ophthalmology,
& pulmonary general
surgery | Intended for use in
general and cosmetic
dentistry,
otolaryngology/ENT
surgery, dermatology and
plastic surgery, oral
maxillofacial and cosmetic
surgery, and podiatry | Intended for use in
dentistry, dermatology,
general surgery, and
podiatry | Indicated for ablating,
incising, excising,
vaporization, and
coagulation of soft
tissues. The device will be
used in general and
cosmetic dentistry,
otolaryngology,
dermatology, and plastic
surgery. | Indicated for
incision/excision, ablation
and coagulation
(homeostasis) of soft
tissue and cartilage.
Specific surgical
specialties include
dentistry, oral surgery, ear,
nose & throat (ENT), head
and neck surgery, thoracic
surgery, neurology
(homeostasis only),
dermatology, plastic
surgery, 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 (