Who is the manufacturer of Ultrafast, Ultrafast Plus, Ultrafast Lite?

Dentlight, Inc. filed the 510(k) submission for Ultrafast, Ultrafast Plus, Ultrafast Lite (K201387).

What is the FDA product code for Ultrafast, Ultrafast Plus, Ultrafast Lite?

NVK. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Ultrafast, Ultrafast Plus, Ultrafast Lite?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Ultrafast, Ultrafast Plus, Ultrafast Lite?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ultrafast, Ultrafast Plus, Ultrafast Lite

K201387 · Dentlight, Inc. · NVK · Feb 26, 2021 · General, Plastic Surgery

Device Facts

Record ID	K201387
Device Name	Ultrafast, Ultrafast Plus, Ultrafast Lite
Applicant	Dentlight, Inc.
Product Code	NVK · General, Plastic Surgery
Decision Date	Feb 26, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following: · Gingival troughing for crown impression · Gingivectomy · Gingivoplasty · Gingival incision and excision · Hemostasis and coagulation · Excisional and incisional biopsies · Exposure of unerupted teeth · Fibroma removal · Frenectomy and frenotomy · Implant recovery · Incision and drainage of abscess · Leukoplakia · Operculectomy · Oral papillectomies · Pulpotomy · Pulpotomy as an adjunct to root canal therapy · Reduction of gingival hypertrophy · Soft tissue crown lengthening · Treatment of canker sores, herpetic and ulcers · Vestibuloplasty · Tissue retraction for impression Laser periodontal indications including: · Sulcular debridernent (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility). · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.

Device Story

Cordless diode laser system for dental soft tissue procedures; utilizes solid-state laser diodes (808nm or 980nm) to generate infrared radiation. Energy delivered via single-use fiber optic tip to treatment site. Handpiece contains laser diode, control circuitry, microprocessor, and rechargeable battery. Includes green aiming beam for procedure guidance. Operated by dentists in clinical settings. Provides visual/audible notifications via LCD interface. Enables precise tissue management (incision, coagulation, ablation); benefits include improved clinical indices in periodontal pockets and efficient soft tissue surgery.

Clinical Evidence

Bench testing only. Device performance verified through optical, thermal, electrical, and mechanical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Diode laser system; wavelengths 808nm or 980nm; max CW power 1.5W-3W. Handpiece constructed of anodized aluminum. Single-use fiber optic delivery (400μm core). Powered by rechargeable Lithium-ion battery. Includes LCD interface, green aiming beam (525nm). Sterilization/Biocompatibility per ISO 10993-1. Compliance with IEC 60601-1, 60601-1-2, 60825-1, 60601-2-22.

Indications for Use

Indicated for dental soft tissue procedures including incision, excision, vaporization, ablation, and coagulation in patients requiring oral soft tissue management, periodontal pocket debridement, or treatment of oral lesions.

Regulatory Classification

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.

Predicate Devices

Styla Microlaser (K081214)

Reference Devices

K2 Mobile (K200693)

Related Devices

K152032 — ELUMI 810 + 980 Soft Tissue Laser · Azena Medical, LLC · Sep 16, 2015
K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) · Medency S.R.L. · Nov 27, 2023
K230047 — Medical Diode Laser Systems · Gigaalaser Company , Ltd. · Mar 4, 2024
K171986 — Sterling Supreme Diode Laser · CAO Group, Inc. · Sep 22, 2017
K162114 — Photon, Photon Plus · Zolar Technology & Mfg Co., Inc. · Dec 12, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 26, 2021 DentLight Inc. Richard Liu President 1825 Summit Ave. Ste 210 Plano, Texas 75074 Re: K201387 Trade/Device Name: Ultrafast, Ultrafast Plus, Ultrafast Lite 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: NVK, GEX Dated: February 9, 2021 Received: February 12, 2021 Dear Richard Liu: 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 {1}------------------------------------------------ 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 (OS) 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, For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### III. Indications for Use DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K201387 #### Device Name Ultrafast/Ultrafast Plus/Ultrafast Lite #### Indications for Use (Describe) Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following: - · Gingival troughing for crown impression - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation - · Excisional and incisional biopsies - · Exposure of unerupted teeth - · Fibroma removal - · Frenectomy and frenotomy - · Implant recovery - · Incision and drainage of abscess - · Leukoplakia - · Operculectomy - · Oral papillectomies - · Pulpotomy - · Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and ulcers - · Vestibuloplasty - · Tissue retraction for impression Laser periodontal indications including: · Sulcular debridernent (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility). · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ #### IV. 510(k) Summary ### K201387 This summary of 510(k) substantial equivalence is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. ### 1. APPLICANT DentLight Inc. 1825 Summit Ave., Suite 210 Plano, TX 75074 Phone: 972-889-8857 Fax: 972-346-6550 Contact Person: Richard Liu Date Prepared: Feb. 8, 2021 ## 2. DEVICE NAME Proprietary Name: Ultrafast/Ultrafast Plus/Ultrafast Lite Common/Usual Name: Dental Diode Laser Classification Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (878.4810) Product Code: GEX ## 3. PRIMARY PREDICATE DEVICE Styla Microlaser (K081214), manufactured by Zap Lasers, LLC. ### REFERENCE DEVICE K2 Mobile (K200693), manufactured by Hu Laser. ### 4. INTENDED USE / INDICATIONS FOR USE Dental soft tissue indications: incision, excision, vaporization, and coagulation of oral soft tissues including the following: - Gingival troughing for crown impression - · Gingivectomy - Gingivoplasty - · Gingival incision and excision - Hemostasis and coagulation - · Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Frenectomy and frenotomy - Implant recovery - · Incision and drainage of abscess - · Leukoplakia {4}------------------------------------------------ - Operculectomy - · Oral papillectomies - · Pulpotomy - Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and ulcers - · Vestibuloplasty - · Tissue retraction for impression Laser periodontal indications including: · Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility). · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. ## 5. DEVICE DESCRIPTION The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip. The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models: | Trade Name | Wavelength (nm) | Max CW Power (Watt) | |----------------|-----------------|---------------------| | Ultrafast | 808 | 3 | | Ultrafast Plus | 980 | 3 | | Ultrafast Lite | 808 | 1.5 | ## 6. DEVICE CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the primary predicate device Styla Microlaser (K081214), manufactured by Zap Lasers, LLC (now Denmat) and the reference device K2 Mobile (K200693), manufactured by Hu Laser. A comparison table on performance and technology with the predicate and reference devices lists key features and characteristics of the subject and predicate devices. It shows the subject products have technology characteristics as the predicate devices. {5}------------------------------------------------ ## Subject Device Performance and Technological Comparison | Parameter\ Name | | Ultrafast / Ultrafast Plus /Ultrafast Lite | Styla Microlaser (Primary Predicate Device) | K2 MOBILE (Reference Device) | |-------------------------------|-------------------------------|--------------------------------------------------------------------|---------------------------------------------|---------------------------------------------| | | Manufacturer | DentLight | Zap Laser/Denmat | Hu Laser | | 510(k) Number | | K201387 | K081214 | K200693 | | | Light Source | Diode Laser | Diode Laser | Diode Laser | | | Regulation Number | 878.4810 | 878.4810 | 878.4810 | | | Device Class | II | II | II | | | Product Code | GEX | GEX | GEX | | Peak Wavelength | | 808±10 nm (Ultrafast/Ultrafast Lite) 980±10 nm (Ultrafast Plus) | 808±5 nm | 980±10 nm | | Maximum CW Power (Watt) | | 3 (Ultrafast/Ultrafast Plus) 1.5 (Ultrafast Lite) | 1.5 | 3.5 | | | | | | | | Maximum Pulse Power (Watt) | | 5 (Ultrafast/Ultrafast Plus) 2 (Ultrafast Lite) | 2 | 6 | | | | | | | | | Power Accuracy (W) | ±20% | ±20% | ±20% | | | Fiber Core Diameter (μm) | 400 | 400 | 400 | | | Aiming Beam | 525 (±10nm, 0.6mW) | 650 (±10nm, 0.5mW) | 635 (5 mW) | | | OPERATION MODE | Continuous / Pulse | Continuous / Pulse | Continuous / Pulse | | | Display | LCD | OLED | OLED | | | Audible Notification | Yes | Yes | Yes | | | Visual Notification | Yes | Yes | Yes | | | Length (without fiber tip) | 163 | 175 | 205 | | Weight | Handpiece | 100 | 55 | 135 | | (grams) | Charging Stand | 88 | 340 | 150 | | | Battery | Lithium ion | Lithium ion | Lithium ion | | | Power Supply Input | 100-240V, 50/60Hz | Input: 100-240V, 50-60Hz | Input: 100-240V, 50-60Hz | | | Structure | Ergonomic aluminum wand | Ergonomic aluminum wand | Ergonomic aluminum/plastic wand | | Compliance Standards | | IEC 60601-1; IEC 60601-1-2; IEC 60825-1; IEC 60601-2-22 | IEC 60601-1; IEC 60825-1; IEC 60601-2-22 | IEC 60601-1; IEC 60825-1; IEC 60601-2-22 | ## Subject Device Indications for Use Comparisons | Parameter Name | Ultrafast / Ultrafast Plus /Ultrafast Lite | Styla Microlaser (Primary Predicate Device) | K2 MOBILE (Reference Device) | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | DentLight | Zap Laser/Denmat | Hu Laser | | 510(k) Number | K201387 | K081214 | K200693 | | Indications for Use | Dental soft tissue indications: incision, excision, vaporization, ablation, and coagulation of oral soft tissues including the following: • Gingival troughing for crown impression • Gingivectomy • Gingivoplasty • Gingival incision and excision • Hemostasis and coagulation • Excisional and incisional | Intended for ablating, incising, excising, vaporizing, and coagulation of oral soft tissues using a contact fiber optic delivery system. The following are the oralpharngeal indications for use for which the device will be marketed: • Excisional and incisional biopsies • Hemostasis assistance | 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: • Biopsies • Crown lengthening • Exposure of unerupted teeth • Fibroma removal | DentLight Inc. 510(k) - K201387 Feb. 8, 2021 {6}------------------------------------------------ | biopsies | • Treatment of aphthous ulcers | • Frenectomy | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Exposure of unerupted teeth | • Frenectomy and frenotomy | • Gingival troughing | | • Fibroma removal | • Gingival Incision and Excision | • Gingivectomy | | • Frenectomy and frenotomy | • Gingivectomy | • Gingivoplasty | | • Implant recovery | • Gingivoplasty | • Pulpotomy | | • Incision and drainage of abscess | • Incision and drainage of abscess | • Root canal therapy | | • Leukoplakia | • Operculectomy | • Hemostasis and coagulation | | • Operculectomy | • Oral papillectomy | • Leukoplakia | | • Oral papillectomies | • Removal of fibromas | • Implant recovery | | • Pulpotomy | • Soft tissue crown lengthening | • Incision and drainage of abscess | | • Pulpotomy as an adjunct to root canal therapy | • Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) | • Operculectomy | | • Reduction of gingival hypertrophy | • Vestibuloplasty | • Papillectomies | | • Soft tissue crown lengthening | | • Reduction of gingival hypertrophy | | • Treatment of canker sores, herpetic and aphthous ulcers | | • Treatment of Aphthous- ulcer canker sores and herpetic | | • Vestibuloplasty | | •Vestibuloplasty | | • Tissue retraction for impression | | | | Laser periodontal indications including: | | Periodontal procedures: | | • Sulcular debridement (curettage, removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility). | | • Sulcular debridement | | • Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket. | | • 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 | | | | • Laser Assisted whitening | Similarities between Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices: - · Ultrafast/Ultrafast Plus/Ultrafast Lite have the same indications for use as the predicate/reference devices. - · Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent operating modes as the predicate/reference devices. - · Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent design, construction materials, weight, size, performance characteristics and key features as the predicate/reference devices. - · Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the predicate/reference devices in standards compliance. ## Differences between the Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices: Ultrafast/Ultrafast Plus/Ultrafast Lite have an LCD display instead of an OLED display by the predicate and reference devices. They use green aiming beams instead of red aiming beams by the predicate and reference devices. The difference in display and aiming beam improves the operator's ease of use and does not raise any substantial equivalence concerns as it has similar performance of the predicate and reference devices. The device modifications do not potentially alter the fundamental scientific technology of the device. # 7. NON-CLINICAL PERFORMANCE TESTING The subject devices have been tested for optical, thermal, electrical and mechanical safety and comply with the electrical and optical safety requirements as the predicate devices: IEC 6060-1, IEC 60601-1-2, IEC 60825-1 and IEC 60601-2-22. {7}------------------------------------------------ The subject devices have been tested for biocompatibility and comply with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The subject devices have tested and verified to meet all design specifications that are substantially equivalent to the predicate devices. #### 8. CONCLUSION Based on similarities in indications for use and technology together with results from performance testing, we believe that Ultrafast Plus/Ultrafast Lite Diode Lasers are substantially equivalent to the predicate devices.