The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria for a device, nor does it describe a study that proves a device meets specific acceptance criteria in the manner requested.

The document is an FDA 510(k) clearance letter for the LUNE™ PureHygiene dental laser system. It states that the device is substantially equivalent to a predicate device (Epic Pro/Hygiene Biolase). The "Summary of Performance Data (Nonclinical and/or Clinical)" section on page 5 lists non-clinical tests performed (Electrical Safety, EMC, Laser Safety, Software V&V, Design Verification, Reprocessing Validation, Biocompatibility Assessment) but explicitly states "N/A" for "Clinical Tests."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no clinical study or specific performance acceptance criteria are detailed in this document.

The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, supported by non-clinical testing.

Summary

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 25, 2024

Enamel Pure % Dhaval Saraiya Regulatory Affairs and Quality Assurance Consultant Omnee Strategic Solutions, Inc. 7 Desrosiers Landing South Grafton, Massachusetts 01560

Re: K234085

Trade/Device Name: LUNETM PureHygiene 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: December 22, 2023 Received: December 26, 2023

Dear Dhaval Saraiya:

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.

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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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-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 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.

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-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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, 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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K234085

Device Name

LUNE™ PureHygiene

Indications for Use (Describe)

Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:
• Reduction of bacterial level (decontamination)

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)

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Image /page/4/Picture/0 description: The image shows the logo for Enamel Pure. The logo consists of a diamond shape that is split into two triangles, with the top triangle being green and the bottom triangle being blue. A curved line wraps around the diamond. To the right of the diamond is the word "ENAMELPure" in a serif font, with "ENAMEL" in green and "Pure" in blue. Underneath the word "ENAMELPure" is a curved blue line.

K234085 - 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the LUNE PureHygiene 510(k) premarket notification.

Sponsor:	Enamel Pure Inc.Nathan Monty17 Briden StreetWorcester, MA 01605
Contact Person:	Dhaval S.Omnee Strategic Solutions, Inc.Regulatory/Quality ConsultantEmail: omneestrategicsol@gmail.com
Date:	Mar 21, 2024
Subject Device:	Trade Name: LUNE™ PureHygieneCommon Name: Dental Laser SystemClassification Name: Laser surgical instrument foruse in general and plastic surgery and indermatology - (21 CFR 878.4810)GEX – Powered Laser Surgical Instrument
Predicate Device(s):	Primary Predicate: K193486 Epic Pro/Hygiene BiolaseReference Device: K221761 Solea Convergent Dental

Purpose and Device Description:

The purpose of this submission is to request clearance for the new LUNE PureHygiene. The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.

Intended Use and Indications for Use:

Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:

. Reduction of bacterial level (decontamination)

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: The intended use is similar to the intended use cleared in K193486. ●

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Image /page/5/Picture/0 description: The image shows the logo for Enamel Pure. The logo features a green and blue diamond shape on the left, with the text "EnamelPure" in green next to it. A blue wave-like line is underneath the text.

Indications for Use: The indications for use are similar to the indications for use cleared in K193486. ●
Design Features: The design features are similar to those in currently marketed devices cleared in K193486 and K221761.

Summary of Performance Data (Nonclinical and/or Clinical):

Non-Clinical Tests: ●

Electrical Safety Testing per IEC 60601-1 o
O EMC Testing per IEC 60601-1-2
Laser Safety Testing per IEC 60601-2-22 & IEC 60825-1 o
O Software Verification and Validation
Design Verification tooth temperature, bacterial reduction, and user validation O
Reprocessing Validation (cleaning and sterilization) per the FDA Reprocessing Guidance o
Biocompatibility Assessment per ISO 10993-1 and the FDA Biocompatibility Guidance o

Clinical Tests: ●

o N/A

Substantial Equivalence

The LUNE PureHygiene has been shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses.

Property orCharacteristic	Proposed DeviceLUNE PureHygiene	Predicate DeviceEpic Pro/Hygiene(K193486)	Reference DeviceSolea(K221761)
FDA ProductCode(s)	GEX	GEX	GEX
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
ClassificationName	Powered Laser Surgical Instrument	Powered Laser SurgicalInstrument	Powered Laser Surgical Instrument
Indications forUse	Enamel Pure LUNE PureHygieneis indicated for the following indental hard tissue:● Reduction of bacterial level(decontamination)	Biolase Epic Pro/Hygiene isindicated for the following:● Reduction of bacterial level(decontamination) andinflammationPlease refer to K193486 for acomplete list of indications.	The Solea system is indicated forthe following:● Aiding in the reduction ofmineral loss in dental enamel● Ablation of hard tissue forcaries removal and cavityprevention● Incision, excision, vaporization,coagulation and hemostasis ofsoft tissue in the oral cavity● Cutting, shaving, contouringand resection of oral osseoustissue (both)
OperatingVoltage	100V-240V	100V-240V	100V-240V

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Image /page/6/Picture/0 description: The image shows the logo for Enamel Pure. The logo features a green and blue diamond shape with a curved line around it on the left side. The text "ENAMELPURE" is written in green and blue on the right side of the diamond.

Property orCharacteristic	Proposed DeviceLUNE PureHygiene	Predicate DeviceEpic Pro/Hygiene(K193486)	Reference DeviceSolea(K221761)
Frequency	50/60 Hz	50/60 Hz	50/60 Hz
Main Control	Main Power Switch	Main Power Switch	Main Power Switch
RemoteInterruption	Remote Interlock - Rear	Remote Interlock - Rear	Remote Interlock - Rear
Disable Control	Emergency Stop Button	Emergency Stop Button	Emergency Stop Button
Laser Source	Treatment - CO2Aiming - Diode laser	Treatment - Semi-conductordiodeAiming - Diode laser	Treatment - CO2Aiming - Diode laser
LaserActivation	Footswitch	Footswitch	Footswitch
LaserClassification	Treatment – Class IVAiming - Class 2	Treatment – Class IVAiming - Class 2	Treatment – Class IVAiming - Class 2/3R
Delivery System	Articulating Arm and handpiece	Fiber optic cable, handpiece anddisposable tips	Articulating Arm and handpiece
Handpiece	Medical grade Radel	Stainless Steel	Stainless Steel
SterilizationMethod	Steam Autoclave (Handpiece only)	Steam Autoclave (Handpieceonly)	Steam Autoclave (Handpiece only)

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.