Dental Diode Laser Device (Laser-Pen)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 18, 2026 Guilin Kevin Peter Technology Co., Ltd. Libin Zhang Regulatory Affairs Manager North Side Of Linsu Rd., Lingui Town, Lingui Dist. Guilin, Guangxi 541100 China Re: K261047 Trade/Device Name: Dental Diode Laser Device (Laser-Pen) 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: March 31, 2026 Received: March 31, 2026 Dear Libin Zhang: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261047 - Libin Zhang Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K261047 - Libin Zhang Page 3 Sincerely, For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261047 | ? | | Please provide the device trade name(s). | | ? | | Dental Diode Laser Device (Laser-Pen) | | | | Please provide your Indications for Use below. | | ? | | Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy Periodontal procedures: Sulcular debridement Implant procedures: Implant recovery Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy,Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty Other procedures: Gingival troughing, Hemostasis and coagulation Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Premarket Notification Submission # **K261047 - 510(k) Summary** Date Prepared: September 15, 2026 Manufacturer: Guilin Kevin Peter Technology Co., Ltd North side of Linsu Rd, Lingui Town, Lingui Dist., Guilin, Guangxi 541100, P. R. China Contact Person: Zhang Libin Regulatory Affairs Manager Guilin Kevin Peter Technology Co., Ltd Tel: +86-773-2352685 E-mail: zhanglb@kvpeter.com # **Identification of the Device:** Proprietary/Trade Name: Laser-Pen Device Name: Dental Diode Laser Device Classification Name: Powered Laser Surgical Instrument Regulatory Number: 21 CFR 878.4810 Product Code: GEX Device Class: Class II Review Panel: General & Plastic Surgery # **Identification of the Legally Marketed Predicate Device:** # **Predicate Device 1:** Trade Name: K2 MOBILE Device Name: Dental Diode Laser Device Classification Name: Powered Laser Surgical Instrument Regulatory Number: 21 CFR 878.4810 Product Code: GEX Device Class: Class II Review Panel: General & Plastic Surgery Submitter/510(k) Holder: HULASER, Inc. Clearance: K200693 # **Predicate Device 2:** Trade Name: Epic 980 Device Name: Dental Diode Laser Device Classification Name: Powered Laser Surgical Instrument Regulatory Number: 21 CFR 878.4810 1 {5}  510(k) Premarket Notification Submission | Product Code: | GEX, ILY | | --- | --- | | Device Class: | Class II | | Review Panel: | General & Plastic Surgery | | Submitter/510(k) Holder: | Biolase, Inc. | | Clearance: | K192430 | # **Device Description:** The Dental Diode Laser Device (Model: Laser-Pen) emits non-ionizing laser radiation via a semiconductor laser. The laser energy is delivered to the treatment area through a optical fiber tip. Several types of optical fiber tip are available for use with the therapy device to accommodate different surgical procedures. This product consists of the main unit (including semiconductor laser, battery, cooling system, control system, and display system), silicone sleeve, base, optical fiber tip (MF2-14, MF2-20, MF3-4, MF3-9, MF4-4, MF4-9), Physiotherapy stick (DT30-Tip, DT20-Tip, DT15-Tip, BT8-Tip), Whiting tip, power adapter, cutting pen, Fiber optic articulating paper, bending tool and googles. # **Indications for Use:** Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: # **Endodontic procedures:** Pulpotomy, Root canal therapy # **Periodontal procedures:** Sulcular debridement # **Implant procedures:** Implant recovery # **Surgery procedures:** Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty # **Other procedures:** Gingival troughing, Hemostasis and coagulation Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local 2 {6}  510(k) Premarket Notification Submission blood circulation; the temporary relation of muscle. **FDA Guidance Documents:** - Format for Traditional and Abbreviated 510(k)s Guidance issued on September 13, 2019 - Electronic Submission Template for Medical Device 510(k) Submissions issued on October 2, 2023. - Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff JUNE 2022 - Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff JUNE 2023 **Comparison with Predicate Device:** The subjected Dental Diode Laser Device (Model: Laser-Pen) and the predicted device are equivalent in the indications for use, Principle of operation, performance characteristics and technical specification. **Substantial Equivalence:** The comparison between the overall specifications of predicate device (K2 MOBILE (K200693), Epic 980 (K192430)) and the new device (Laser-Pen Dental Diode Laser Device) is shown in Table 1. Any differences between the predicate and the new device have no impact on safety or efficacy and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices. **Table 1: Substantial equivalence discussion** | | Subject Device Dental Diode Laser Device (Model: Laser- Pen) | Predicate Device 1 K2 MOBILE | Predicate Device 2 Epic 980 | | --- | --- | --- | --- | | Manufacturer | Guilin Kevin Peter Technology Co., Ltd | HULASER, Inc. | Biolase, Inc. | | Device Name | Dental Diode Laser Device (Model: Laser- Pen) | K2 MOBILE | Epic 980 | | 510(k) number | K261047 | K200693 | K192430 | | Product Code | GEX | GEX | GEX, ILY | 3 {7}  # 510(k) Premarket Notification Submission | | Subject Device Dental Diode Laser Device (Model: Laser- Pen) | Predicate Device 1 K2 MOBILE | Predicate Device 2 Epic 980 | | --- | --- | --- | --- | | Regulatory Class | 2 | 2 | 2 | | Principle of operation | Laser diode is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber. | Laser diode is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber. | The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site. A visible light is emitted at the same time to visually identify the treatment location. | | Laser Medium | Diode Laser | Diode Laser | Diode Laser | | Laser Classification | Class IV (4) Laser | Class IV (4) Laser | Class IV (4) Laser | | Laser Wavelength | 980nm | 980nm | 980nm | | Laser Power range | 0~6W | 0~6W | 10W (Max) | | Operation mode | Continuous (CW) mode, Pulse mode | Continuous (CW) mode, Pulse mode | Continuous (CW) mode, Pulse mode | | Pulse width/interval | On/off time: 50ms (Pulse mode 1) On/off time: 5ms (Pulse mode 2) | On/off time: 50ms (Pulse mode 1) On/off time: 5ms (Pulse mode 2) | 0.01 - 20 ms 0.04 – 20 ms | | Pulse repetition | 10Hz (Pulse mode 1) 100Hz (Pulse mode 2) | 10Hz (Pulse mode 1) 100Hz (Pulse mode 2) | Up to 20 kHz | 4 {8} [LOGO] 510(k) Premarket Notification Submission | | Subject Device Dental Diode Laser Device (Model: Laser-Pen) | Predicate Device 1 K2 MOBILE | Predicate Device 2 Epic 980 | | --- | --- | --- | --- | | rate | | | | | Aiming Beam | 650nm, 5 mW | 635nm, 5 mW | 625- 670 nm, max 1mW | | Tips type | Optical fiber tip Physiotherapy sticks Whitening tip | Optical fiber tip | Optical fiber tip Physiotherapy sticks Whitening tip | | Optical fiber tip (core diameter ) | 200 μm, 300 μm, 400 μm | 400 μm | 200 μm, 300 μm, 400 μm | | Physiotherapy sticks (Spot size) | 8mm, 15mm, 20mm, 30mm | / | 30mm | | Whitening tip (Spot size) | 24.8mm×11.8mm | / | 35mm×8mm | | Power Input | Rechargeable Lithium Ion battery: 3.7V, 3100 mAh (Battery charger: AC 100-240V, 50/60Hz) | Rechargeable Lithium Ion battery: 3.7V, 1700 mA (Battery charger: AC 100-240V, 47-63Hz) | AC 90-230V, 0.8A, 50-60Hz; Battery: Lithium ion 3.7 V 800 mAh | | Prescription or OTC | Prescription | Prescription | Prescription | | Intended User | Licensed practitioner | Licensed practitioner | Licensed practitioner | Table 2: Indication for Use | Subject Device Dental Diode Laser Device (Model: Laser-Pen) | Predicate Device 1 K2 MOBILE | Predicate Device 2 Epic 980 | | --- | --- | --- | 5 {9}  510(k) Premarket Notification Submission | Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: | K2 mobile laser is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: | Dental soft tissue indications Incision, excision, vaporization, ablation, and coagulation of oral soft tissue including marginal and inter-dental gingiva and epithelial lining of free gingiva, Laser Periodontal Procedures, Whitening, Pain Relief. The Specific indications are as follows: | | --- | --- | --- | | **Endodontic procedures:** | | | | pulpotomy | pulpotomy | Pulpotomy | | root canal therapy | root canal therapy | Pulpotomy as an adjunct to root canal therapy | | **Periodontal procedures:** | | | | Sulcular debridement | Sulcular debridement | sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) | | **Implant procedures:** | | | | Implant recovery | Implant recovery | Implant recovery | | **Surgery procedures:** | | | | Biopsies | Biopsies | Excisional and incisional biopsies | | Crown lengthening | Crown lengthening | Soft tissue crown lengthening | | Exposure of unerupted teeth | Exposure of unerupted teeth | Exposure of unerupted teeth | | Fibroma removal | Fibroma removal | Fibroma removal | | Frenectomy | Frenectomy | Frenectomy | | Gingivectomy | Gingivectomy | Gingivectomy | | Gingivoplasty | Gingivoplasty | Gingivoplasty | | Incision and drainage of abscess | Incision and drainage of abscess | Incisions and draining of abscesses | | Operculectomy | Operculectomy | Operculectomy | | Papillectomies | Papillectomies | Oral papillectomies | 6 {10}  # 510(k) Premarket Notification Submission | Reduction of gingival hypertrophy | Reduction of gingival hypertrophy | Reduction of gingival hypertrophy | | --- | --- | --- | | Vestibuloplasty | Vestibuloplasty | Vestibuloplasty | | **Others procedures:** | | | | Gingival troughing | Gingival troughing | Gingival troughing for crown impressions | | Hemostasis and coagulation | Hemostasis and coagulation | Hemostasis and coagulation | | Leukoplakia | Leukoplakia | Leukoplakia | | Treatment of aphthous-ulcer canker sores and herpetic | Treatment of aphthous-ulcer canker sores and herpetic | Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa | | Laser Assisted whitening | Laser Assisted whitening | Laser assisted whitening /bleaching of teeth | | Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relation of muscle | Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relation of muscle | Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscle back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. | | / | / | Frenotomy Gingival incision and excision Tissue retraction for impressions Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal packet Laser activation for bleaching materials for teeth whitening | The subjected Dental Diode Laser Device (Model: Laser-Pen) and the predicted device are equivalent in the indications for use, Principle of operation, performance characteristics and technical specification. The differences 7 {11} [LOGO] 510(k) Premarket Notification Submission between the proposed device and the predicate device will not raise any new issues of safety or effectiveness. ### Summary of Testing: ### Summary of Non-Clinical Tests: ### Reprocessing We tested and validated the reprocessing process according to FDA reprocessing guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”. The results show that the designed reprocessing processes are effective to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. - ISO 17664-1: 2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices - ISO 17664-2: 2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. ### Biocompatibility The biocompatibility tests of patient contact part were performed in accordance with the following FDA recognized standards - ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization - ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation ### Electrical Safety and Electromagnetic Compatibility Summary The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards: - IEC60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: 8 {12}  510(k) Premarket Notification Submission General requirements for basic safety and essential performance - ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] - IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems - IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency. - IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment - IEC 62133-2:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems - 21 CFR 1040.10 Laser products - 21 CFR 1040.11 Specific purpose laser products ### Performance Testing - Nonclinical 1) Laser performance - Classification, Accessible emission level The test was performed in in accordance with the FDA recognized standard, IEC 60825- 1:2014, Safety of laser products - Part 1: Equipment classification and requirements, Clause 9, and 21CFR1040.10. 2) Laser output power testing – Protection against unwanted and excessive output, Accuracy of control The test was performed in accordance with the FDA recognized standard, IEC 60601-2- 22:2007+A1:2012, Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, Clause 201.10 and 201.12, and 21CFR1040.11 ### Summary of Clinical Tests: Clinical studies were not performed for the subject device to support substantial equivalence. ### Conclusion: 9 {13} ## 510(k) Premarket Notification Submission The conclusions drawn from the nonclinical tests demonstrate that the subject device, Dental Diode Laser Device (Model: Laser-Pen) is substantially equivalent to the predicate devices. 10