PerioLase Nd:YAG Pulsed Dental Laser System

{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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ 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<br>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<br>PerioLase | Millennium<br>PerioLase<br>K151763<br>3/15/16 | PinPointe USA<br>PinPointe FootLaser<br>K093547<br>10/15/10 | Fotona<br>LightWalker Nd:YAG<br>K121508<br>12/12/12 | Lares Research<br>SunLase 800 P<br>(PocketPro)<br>K011960<br>12/21/01 | Xintec<br>Dentica<br>K971065<br>6/17/97 | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | General & Plastic Surgery<br>and Dermatology | General & Plastic Surgery<br>and Dermatology | General & Plastic Surgery<br>and Dermatology | General & Plastic Surgery<br>and Dermatology | General & Plastic Surgery<br>and Dermatology | General & Plastic Surgery<br>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<br>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<br>surgery procedures for<br>ablating, incising, excising,<br>vaporizing, and<br>coagulating soft tissues in<br>specialties such as general<br>and cosmetic dentistry,<br>including tooth whitening,<br>modification of dentin<br>surface, temporary relief<br>of pain, oral,<br>maxillofacial, and<br>cosmetic surgery,<br>otolaryngology / ENT<br>surgery, arthroscopy,<br>dermatology and plastic<br>surgery, gastroenterology,<br>general surgery,<br>gynecology, neurosurgery,<br>ophthalmology, podiatry,<br>pulmonary surgery, and<br>urology | Intended for ablating,<br>incising, excising,<br>vaporization and<br>coagulation of soft tissues<br>using a contact fiber-optic<br>delivery system. The<br>device will be used in the<br>following areas: general<br>and cosmetic dentistry,<br>otolaryngology,<br>arthroscopy,<br>gastroenterology, general<br>surgery, dermatology &<br>plastic surgery,<br>neurosurgery, gynecology,<br>urology, ophthalmology,<br>& pulmonary general<br>surgery | Intended for use in<br>general and cosmetic<br>dentistry,<br>otolaryngology/ENT<br>surgery, dermatology and<br>plastic surgery, oral<br>maxillofacial and cosmetic<br>surgery, and podiatry | Intended for use in<br>dentistry, dermatology,<br>general surgery, and<br>podiatry | Indicated for ablating,<br>incising, excising,<br>vaporization, and<br>coagulation of soft<br>tissues. The device will be<br>used in general and<br>cosmetic dentistry,<br>otolaryngology,<br>dermatology, and plastic<br>surgery. | Indicated for<br>incision/excision, ablation<br>and coagulation<br>(homeostasis) of soft<br>tissue and cartilage.<br>Specific surgical<br>specialties include<br>dentistry, oral surgery, ear,<br>nose & throat (ENT), head<br>and neck surgery, thoracic<br>surgery, neurology<br>(homeostasis only),<br>dermatology, plastic<br>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 (< 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<br>(µsec) | 100, 150, 250, 350, 450,<br>550, 650 | 100, 150, 250, 350, 450,<br>550, 650 | 100-700 (6W), 350-3000<br>(30W), 350-3000 (100W) | 100, 180, 650 | 110, 280 | 100, 160, 300, 500, 700 | | Energy per pulse<br>(mJ) | 20-300…