Waterlase iPLus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 21, 2022 Biolase, Inc. Ed Balcos Senior Regulatory Affairs Specialist 27042 Towne Centre Drive, Suite 270 FootHill Ranch, California 92610 Re: K210183 Trade/Device Name: Waterlase iPLus 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, ONG Dated: January 22, 2021 Received: January 25, 2021 Dear Ed Balcos: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known) K210183 Device Name Waterlase iPlus Laser System #### Indications for Use (Describe) Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing. Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) - · Class I, II, III, IV and V cavity preparation - · Caries removal - Hard tissue surface roughening or etching - · Enameloplasty, excavation of pits and fissures for placement of sealants #### Root Canal Hard Tissue Indications - · Tooth preparation to obtain access to root canal - · Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection - · Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications - · Flap preparation incision of soft tissue to prepare a flap and expose the bone - · Cutting bone to prepare a window access to the apex (apices) of the root(s) - Apicoectomy amputation of the root end - · Root end preparation for retrofill amalgam or composite · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - · Cutting, shaving, contouring and resection of oral osseous tissues (bone) - · Osteotomy Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: - · Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - · Flap preparation incision of soft tissue to prepare a flap and expose the bone - · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) {3}------------------------------------------------ - · Frenectomy and frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis - · Implant recovery - Incision and drainage of abscesses - · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulp extirpation - · Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Vestibuloplasty · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures - Full thickness flap - Partial thickness flap - · Split thickness flap - · Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium - · Removal of granulation tissue from bony defects - · Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - · Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - · Osseous crown lengthening - · Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage • Waterlase Er.Cr: Y SGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium. Type of Use (Select one or both, as applicable) |X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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. 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DEVICE | Name of Device: | Waterlase iPlus Laser System, Fractional Handpiece | |----------------------|-------------------------------------------------------------------------------------------------------| | Common Name: | Er, Cr YSGG Laser | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) | | Device Class: | II | | Product Code: | GEX, ONG | #### III. PREDICATE DEVICES Pearl Fractional Handpiece, Cutera, Inc., K080530 FS-01 Handpiece, Fotona, d.d., K132806 REFERENCE DEVICE Waterlase iPlus S, Biolase, Inc., K141975 #### IV. DEVICE DESCRIPTION Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue. The laser consists of a console the houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the issue. The laser is controlled through a touch screen display which serves as the User Interface. {6}------------------------------------------------ # BOLASE #### V. INDICATIONS FOR USE Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing. #### Waterlase iPlus when used with non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) - Class I, II, III, IV and V cavity preparation ● - Caries removal o - Hard tissue surface roughening or etching o - Enameloplasty, excavation of pits and fissures for placement of sealants ● #### Root Canal Hard Tissue Indications - Tooth preparation to obtain access to root canal - Root canal preparation including enlargement ● - Root canal debridement and cleaning ● ### Root Canal Disinfection - Laser root canal disinfection after endodontic treatment 0 #### Endodontic Surgery (Root Amputation) Indications - Flap preparation incision of soft tissue to prepare a flap and expose the bone ● - Cutting bone to prepare a window access to the apex (apices) of the root(s) - Apicoectomy amputation of the root end o - Root end preparation for retrofill amalgam or composite ● - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic ● tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. #### Bone Surgical Indications - Cutting, shaving, contouring and resection of oral osseous tissues (bone) ● - Osteotomy ● ## Soft Tissue Indications including Pulpal Tissues (for use on adult and pediatric patient) - Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: - Excisional and incisional biopsies ● - Exposure of unerupted teeth - Fibroma removal - Flap preparation incision of soft tissue to prepare a flap and expose the bone ● {7}------------------------------------------------ ## K210183 # BIOLASE - Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth ● (hard and soft tissue impactions) - Frenectomy and frenotomy - Gingival troughing for crown impressions - Gingivectomy ● - Gingivoplasty - Gingival incision and excision - Hemostasis - Implant recovery ● - Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - Leukoplakia - Operculectomy ● - Oral papillectomies - Pulpotomy - Pulp extirpation ● - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning ● - Reduction of gingival hypertrophy - Soft tissue crown lengthening ● - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ● - Vestibuloplastv ● - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic . tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. ### Laser Periodontal Procedures - Full thickness flap ● - Partial thickness flap - Split thickness flap - Laser soft tissue curettage ● - Laser removal of diseased, inflamed and necrosed soft tissue within the ● periodontal pocket - o Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium - Removal of granulation tissue from bony defects ● - Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for ● {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the word "BIOLASE" in large, bold, blue letters. The letters are closely spaced together, filling most of the frame. The background is white. grafting, etc.) - Osseous crown lengthening - o Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage - . Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | Subject Device | Predicate<br>(primary) | Predicate<br>(secondary) | Reference<br>Device | |-------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------|---------------------| | Specification | Biolase Fractional<br>Handpiece | Cutera Pearl<br>Fractional<br>Handpiece | Fotona FS01<br>Fractional<br>Handpiece | Biolase iPlus S | | 510(k) Number | K210183 | K080530 | K132806 | K141975 | | Laser medium | Er,Cr YSGG | Er YSGG | Er YAG | Er,Cr YSGG | | Wavelength | 2780 nm | 2790 nm | 2940 nm | 2780 nm | | Operating modes | pulsed | pulsed | pulsed | pulsed | | Pulse width, us | 60 µs, 700 µs | < 1000 µs | 100 us, 300 us | 60 μs, 700 μs | | Max Rep Rate | 15 Hz | 20 Hz | 50 Hz | 100 Hz | | Spot size | 250 µm | 300 µm | 250 µm | 200 – 1200μm | | Spot spacing | 900 µm in x<br>direction, 1 mm in y<br>direction (based on<br>1.5 cm/sec speed of<br>movement) | 0.6 mm (based<br>on 20%<br>density) | 1.1 mm | N/A | | Max energy per<br>spot | 40 mJ | 200 mJ | 22 mJ | 600 mJ | | Max fluence per<br>spot | 82 J/cm2 | 280 J/cm2 | 45 J/cm2 | 425 J/cm2 | {9}------------------------------------------------ # BIOLASE ### VII. PERFORMANCE DATA The following non-clinical and clinical performance information was provided in support of substantial equivalence determination: #### Biocompatibility Testing The biocompatibility evaluation for Waterlase iPlus Laser System was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The addition of the Fraction Handpiece accessory cytotoxicity testing was completed on the only patient contacting disposable accessory applicator. #### Software Verification and Validation Software verification and validation were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices The results demonstrate that the Waterlase iPlus Laser System performs according to specifications and functions intended. The software design conforms with the IEC 62304 standard -Medical device software- software life cycle processes. ### Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted for the Waterlase iPlus Laser System. The device complies with the current revisions of the recognized standards IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 80601-2-60 for safety and IEC 60601-1-2 for EMC. #### Performance Testing- Bench In an effort to ensure adding this accessory handpiece to the iPlus Laser System as well as the dermatological indication was as safe and effective as the predicate devices performance bench testing was completed. A verification of the Fractional Handpiece and trunk fiber designs was completed to gather data for peak performance settings. Verification of accessory requirements was also completed, and the accessory passed all requirement criteria. ### Performance Testing - Animal Ex-vivo and in-vivo animal tissue testing was conducted to assess the depth and width of penetration produced with the fractional handpiece. The results support that the device can be used to produce fractional beam micro-ablation depths and widths that are within the range of other fractional laser devices cleared for dermatological skin resurfacing. {10}------------------------------------------------ ## BIOLASE ## VIII. CONCLUSION The performance data provided in this submission supports that the device can be used safely and effectively and as intended. The proposed device's fractional handpiece's technology does not raise new types of questions regarding safety and efficacy for it's indications for use when compared to the predicate devices. Based on the above, it can be concluded that the Waterlase iPlus Laser System with Fractional Handpiece is found to be substantially equivalent to the predicate devices.