(94 days)
No
The summary describes a laser-based dental treatment system and does not mention any AI or ML components or capabilities.
Yes
The device is described as a "dental treatment system" that performs a therapeutic action, "reduction of bacterial level (decontamination)", on "dental hard tissue".
No
The device is indicated for "Reduction of bacterial level (decontamination)" using laser energy, which is a therapeutic function, not a diagnostic one. It removes plaque and embedded carbonate, which is a treatment, not a diagnosis.
No
The device description clearly states it is a "mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces" which are hardware components. The performance studies also include hardware-related testing like electrical safety, EMC, and laser safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states that the device uses a laser to treat dental hard tissue directly on the patient. The intended use is the reduction of bacterial levels in the mouth. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body.
Therefore, the Enamel Pure LUNE PureHygiene is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:
- Reduction of bacterial level (decontamination)
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Electrical Safety Testing per IEC 60601-1
- O EMC Testing per IEC 60601-1-2
- Laser Safety Testing per IEC 60601-2-22 & IEC 60825-1
- O Software Verification and Validation
- Design Verification tooth temperature, bacterial reduction, and user validation
- Reprocessing Validation (cleaning and sterilization) per the FDA Reprocessing Guidance
- Biocompatibility Assessment per ISO 10993-1 and the FDA Biocompatibility Guidance
Clinical Tests: - N/A
Results of the non-clinical tests indicate that the device will perform within the intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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 Monty
17 Briden Street
Worcester, MA 01605 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dhaval S.
Omnee Strategic Solutions, Inc.
Regulatory/Quality Consultant
Email: omneestrategicsol@gmail.com |
| Date: | Mar 21, 2024 |
| Subject Device: | Trade Name: LUNE™ PureHygiene
Common Name: Dental Laser System
Classification Name: Laser surgical instrument for
use in general and plastic surgery and in
dermatology - (21 CFR 878.4810)
GEX – Powered Laser Surgical Instrument |
| Predicate Device(s): | Primary Predicate: K193486 Epic Pro/Hygiene Biolase
Reference 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 or
Characteristic | Proposed Device
LUNE PureHygiene | Predicate Device
Epic Pro/Hygiene
(K193486) | Reference Device
Solea
(K221761) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code(s) | GEX | GEX | GEX |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Classification
Name | Powered Laser Surgical Instrument | Powered Laser Surgical
Instrument | Powered Laser Surgical Instrument |
| Indications for
Use | Enamel Pure LUNE PureHygiene
is indicated for the following in
dental hard tissue:
● Reduction of bacterial level
(decontamination) | Biolase Epic Pro/Hygiene is
indicated for the following:
● Reduction of bacterial level
(decontamination) and
inflammation
Please refer to K193486 for a
complete list of indications. | The Solea system is indicated for
the following:
● Aiding in the reduction of
mineral loss in dental enamel
● Ablation of hard tissue for
caries removal and cavity
prevention
● Incision, excision, vaporization,
coagulation and hemostasis of
soft tissue in the oral cavity
● Cutting, shaving, contouring
and resection of oral osseous
tissue (both) |
| Operating
Voltage | 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 or
Characteristic | Proposed Device
LUNE PureHygiene | Predicate Device
Epic Pro/Hygiene
(K193486) | Reference Device
Solea
(K221761) |
|-------------------------------|------------------------------------------|-------------------------------------------------------------|---------------------------------------------|
| Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz |
| Main Control | Main Power Switch | Main Power Switch | Main Power Switch |
| Remote
Interruption | Remote Interlock - Rear | Remote Interlock - Rear | Remote Interlock - Rear |
| Disable Control | Emergency Stop Button | Emergency Stop Button | Emergency Stop Button |
| Laser Source | Treatment - CO2
Aiming - Diode laser | Treatment - Semi-conductor
diode
Aiming - Diode laser | Treatment - CO2
Aiming - Diode laser |
| Laser
Activation | Footswitch | Footswitch | Footswitch |
| Laser
Classification | Treatment – Class IV
Aiming - Class 2 | Treatment – Class IV
Aiming - Class 2 | Treatment – Class IV
Aiming - Class 2/3R |
| Delivery System | Articulating Arm and handpiece | Fiber optic cable, handpiece and
disposable tips | Articulating Arm and handpiece |
| Handpiece | Medical grade Radel | Stainless Steel | Stainless Steel |
| Sterilization
Method | Steam Autoclave (Handpiece only) | Steam Autoclave (Handpiece
only) | Steam Autoclave (Handpiece only) |