Who is the manufacturer of VALO X, VALO X Accessory Lenses?

Ultradent Products, Inc. filed the 510(k) submission for VALO X, VALO X Accessory Lenses (K220471).

What is the FDA product code for VALO X, VALO X Accessory Lenses?

EBZ. It is classified under 21 CFR 872.6070 as a Class 2 device in the Dental panel.

What is the regulatory pathway for VALO X, VALO X Accessory Lenses?

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

What are the predicate devices for VALO X, VALO X Accessory Lenses?

VALO Grand Corded and Accessory Lenses (K210550).

Who can help prepare an FDA 510(k) submission like VALO X, VALO X Accessory Lenses?

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.

VALO X, VALO X Accessory Lenses

K220471 · Ultradent Products, Inc. · EBZ · Feb 22, 2022 · Dental

Device Facts

Record ID	K220471
Device Name	VALO X, VALO X Accessory Lenses
Applicant	Ultradent Products, Inc.
Product Code	EBZ · Dental
Decision Date	Feb 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6070
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

VALO X curing light is a source of illumination for curing photo-activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.

Device Story

VALO X is a dental curing light providing broadband illumination (380-515 nm) for polymerizing photo-activated materials and adhesives; also functions as a diagnostic aid for visualization. Operates via LED light source; powered by rechargeable Li-ion batteries or AC cord adapter. Features include two curing modes and two diagnostic modes (white light, black light). Operated by dentists/dental professionals in clinical settings. Includes accessory lenses (PointCure, ProxiCure, Diffuser, Interproximal, Translume) to augment light delivery for specific tasks like shaping matrices or transillumination. User interface includes buttons, audible cues, and an accelerometer for mode switching via motion. Output affects clinical decision-making by ensuring proper material polymerization and enhancing visual inspection of dental structures/resins. Benefits include improved procedural efficiency and diagnostic clarity.

Clinical Evidence

Bench testing only. Performance verified against ISO 10650:2018, IEC 80601-2-60:2019, ISO 10993-1:2018, IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 62471:2006. Testing included radiant exitance, illuminance, color temperature, beam profile, duty cycle, EMC, photobiological safety, and disinfection validation.

Technological Characteristics

Materials: Anodized aluminum (wand), Acetal (lens housing), Neodymium (magnets), Polymethylpentene TPX RT18 (lenses). Light source: LED (blue, violet, white). Power: 3.7V Li-ion battery or AC adapter. Connectivity: Standalone. Sterilization: Disinfection (70% IPA, Cidex OPA). Standards: ISO 10650, IEC 80601-2-60, ISO 10993, IEC 60601-1, IEC 62471.

Indications for Use

Indicated for dentists or dental professionals to cure photo-active dental materials and adhesives, and to provide illumination for visualization during oral procedures.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Predicate Devices

VALO Grand Corded and Accessory Lenses (K210550)

Reference Devices

VALO Grand Corded (K190627)

Related Devices

K210550 — VALO Grand Corded and Accessory Lenses · Ultradent Products, Inc. · Mar 1, 2021
K110582 — VALO CORDLESS · Ultradent Products, Inc. · Apr 28, 2011
K190627 — VALO Grand Corded · Ultradent Products, Inc. · Apr 29, 2019
K170101 — Valiant Curing Light · Inter-Med/Vista Dental Products · Jun 8, 2017
K243921 — LED Curing Lights (DB686 HALO) · Foshan Coxo Medical Instrument Co., Ltd. · Apr 11, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. February 22, 2022 Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K220471 Trade/Device Name: VALO X, VALO X Accessory Lenses Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: Class II Product Code: EBZ, EAO, PEO Dated: February 16, 2022 Received: February 18, 2022 Dear Dave Yungvirt: 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 {1}------------------------------------------------ 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, Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220471 Device Name VALO X; VALO X Accessory Lenses #### Indications for Use (Describe) VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo-activated materials and adhesives. 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. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K220471 # 510(k) Summary This summary of substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for VALO™ X and VALO™ X Accessory Lenses. ## l. Applicant's Name and Address Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 | Contact Person: | Mr. Adam Black | |-----------------|----------------------------| | Title: | Regulatory Affairs Manager | | Telephone: | 801-553-4425 | | Fax: | 801-553-4609 | Date Summary Prepared: 09 February 2022 ### II. Name of the Device | Device: | Dental Curing Light | |------------------------------|-----------------------------------| | Trade/Device Name: | VALO™ X; VALO™ X Accessory Lenses | | Review Panel: | Dental | | Regulation Number: | 21 CFR 872.6070 | | Device Class: | Class II | | Classification Product Code: | EBZ | | Subsequent Product Code: | EAQ, PEQ | #### III. Device Description VALO™ X: With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018. The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit. VALO™ X Accessory Lenses: | Accessory | Mode | Description | |----------------|-------------|--------------------------------------------------------------------------------------------| | PointCure Lens | Curing Mode | Augments the VALO X curing light to polymerize composite through a translucent prosthetic. | {4}------------------------------------------------ | ProxiCure Ball | Curing Mode | Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration. | |--------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Diffuser Lens | White Light Diagnostic Aid Mode | Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed. | | Diffuser Lens | Black Light Diagnostic Aid Mode | Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins. | | Interproximal Lens | White Light Diagnostic Aid Mode | Augments the VALO X curing light in visualization of teeth and dental prostheses. | | Translume | Curing or Diagnostic Aid Modes | Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses. | ## IV. Statement of Intended Use VALO X curing light is a source of illumination for curing photo-activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/diffusor lenses are not intended for complete cure of photo-activated materials and adhesives. ## V. Predicate Device VALO X and VALO X Accessory Lenses identified predicate device: K210550 – VALO™ Grand Corded and Accessory Lenses by Ultradent Products. # VI. Comparison of Technological Characteristics ## Predicate technological comparison: The technology, delivery, and intended use of VALO™ X and VALO™ X Accessory Lenses are substantially equivalent to the identified predicate device as outlined in Table 5-1: {5}------------------------------------------------ | Descriptive Information | Devices: VALO™ X; VALO™ X Accessory Lenses | Predicate: VALO™ Grand Corded and Accessory Lenses (K210550) | Differences | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code/ Classification | EBZ, EAQ, PEQ - Class II | EBZ, EAQ, PEQ - Class II | Identical | | Indications for Use | VALO X curing light is a source of illumination for curing photo-activated dental restorative materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/diffusor lenses are not intended for complete cure of photo-activated materials and adhesives. | VALO Grand Corded: The source of illumination for curing photo-activated dental restorative materials and adhesives. Accessory Lenses: The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo- activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives. | Similar | | Intended User | Dentist or dental professional | Dentist or dental professional | Identical | | Device Design: Power Source | VALO X curing light can be powered by an AC power supply or rechargeable batteries. AC Power Supply: | AC Power Supply: Wall powered. Output: 9VDC, 500mA. Input: 100VAC - 240VAC with adapters for international Capability. Ratings: Medical Grade, (UL, CE, RoHS, | Subject device can be used in a cordless mode with batteries or a corded mode with an AC power supply. Both | | | Wall powered. | WEEE) Cord: 6 ft (1.8m), 2.5mm DC connector | power supply options | | | Output: 9VDC, 2.0A. Input: 100VAC - 240VAC, 50-60 Hz with adapters for international capability. Ratings: Medical Grade, (CE, RoHS, REACH) Cord: 6 ft (1.8m), 2.5mm DC connector Battery Power: 1IMR14/65 3.7V 900mAh 3.33 Wh Li- Ion rechargeable battery pack Power On Button: Located on the handle of the wand, back side and front side | Power On Button: Located on the handle of the wand, back side and front side UL Approved | result in the same light output and device performance. Both the batteries and power supply have certifications to applicable electrical safety standards on their own. The subject device was also evaluated for electrical safety in both the corded and cordless configurations. | | Device Design: Operational Modes (Curing EBZ) | VALO X: Standard Power Mode: 1,100 mW/cm² Xtra Power Mode: 2,200mW/cm² VALO X Accessory Lenses: ≥800 mW/cm² (PointCure – Recommended with High Power Mode) (ProxiCure – Recommended with mode suitable for material) | VALO Grand Corded: Standard Power Mode: 900 mW/cm² High Power Plus Mode: 1500mW/cm² Xtra Power Mode: 2100mW/cm² Accessory Lenses: ≥800 mW/cm² (PointCure – Recommended with High Power Mode) (ProxiCure - Recommended with mode suitable for material) | Removal of one curing mode to provide two simplistic curing modes for clinical use. | | Device Design: Operational Modes (Diagnostic EAQ, PEQ) | VALO X Accessory Lenses: ≥25 mW/cm², ≤420 nm wavelength (Diffuser Lens – Black Light Diagnostic Aid Mode) ≥1,000 lx luminescence, 3,800-6,500 K color temperature, ≥75 CRI (Diffuser Lens - White Light Diagnostic Aid Mode) | Accessory Lenses: ≥25 mW/cm², ≤420 nm wavelength (Black Light Lens - Recommended with Standard Curing mode) ≥1,000 lx luminescence, 5,000-6,000 K color temperature, ≥85 CRI (White Light Lens – Recommended with Standard Curing mode) | Similar | | | ≥15,000 lx luminescence (Interproximal Lens - Recommended with Standard Curing mode) ≥500 nm wavelength (Translume Lens, any mode) | ≥15,000 lx luminescence, 500-570nm peak wavelengths (TransLume Green Lens - Recommended with Standard Curing mode) ≥15,000 lx luminescence (Interproximal Lens - Recommended with Standard Curing mode) | | | Device Design: Light Source | LED light, blue and violet wavelengths (Curing mode) LED light, violet or white wavelengths (Diagnostic mode) 12.5mm head size | LED light, blue and violet wavelengths 12mm head size | Additional white LED source was added for the White Light Diagnostic Aid Mode | | Device Design: Accessories | -Barrier Sleeve VALO™, -Blue-Light Blocking Light Shield -PointCure Lens, ProxiCure Ball Lens, Translume Lens, Diffuser Lens, Inter- proximal Lens, | -Barrier Sleeve VALO™, -Blue-Light Blocking Glasses (VALO™ Grand Corded) -PointCure Lens, ProxiCure Ball Lens, Translume Green Lens, Black Light Lens, Inter-proximal Lens, White Light Lens | Blue-Light blocking light shield is used in place of blue-light blocking glasses | | Composition of Materials | VALO X: Aluminum, anodized black VALO X Accessory Lenses: Lens housing - Acetal Lens housing magnet – Neodymium Molded lens – Polymethylpentene TPX RT18 (PointCure, ProxiCure, TransLume Green, Interproximal) Diffuser Lens – Semi-Opaque White Glass | VALO Grand Corded: Aluminum, anodized black Accessory Lenses: Lens housing – Delrin Lens housing magnet – Neodymium Molded lens – Polymethylpentene TPX RT18 (PointCure, ProxiCure, TransLume Green, Interproximal) Black Light Filter - Glass White Light Filter – Type 2 phosphor | Similar | | Technical Specifications: Light Intensity | VALO X: Standard Power Mode: 1,100 mW/cm² Xtra Power Mode: 2,200mW/cm² | VALO Grand Corded: Standard: 900 mW/cm² High: 1,500 mW/cm² | The slight difference in radiant exitance values | | | As measured by traceable Gigahertz spectrum analyzer | Xtra: 2,100 mW/ cm² As measured by traceable Gigahertz spectrum analyzer | is within the applied ISO 10650 standard. | | | VALO X Accessory Lenses: | | | | | ≥800 mW/cm² (PointCure/ProxiCure) | Accessory Lenses: | | | | ≥25 mW/cm², ≤420 nm wavelength (Black Light Lens) | ≥800 mW/cm² (PointCure/ProxiCure) | | | | ≥1,000 lx luminescence, 5,000-6,000 K color temperature, ≥85 CRI (White Light Lens) | ≥25 mW/cm², ≤420 nm wavelength (Black Light Lens) | | | | ≥500nm peak wavelengths (TransLume Green Lens) | ≥1,000 lx luminescence, 5,000-6,000 K color temperature, ≥85 CRI (White Light Lens) | | | | ≥15,000 lx luminescence (Interproximal Lens) | ≥15,000 lx luminescence, 500-570nm peak wavelengths (TransLume Green Lens) | | | | | ≥15,000 lx luminescence (Interproximal Lens) | | | Technical Specifications: Peak Wavelength | VALO X: Nominal values: 380-420nm and 420-515nm | VALO Grand Corded: Nominal values: 395-415nm and 440-480nm | Similar | | | VALO X Accessory Lenses: All lenses match the curing lights peak wavelengths except: ≤420 nm wavelength (Diffuser Lens in Black Light Diagnostic Mode) ≥500 nm peak wavelength (Translume Lens, any mode) | Accessory Lenses: All lenses match the curing lights peak wavelengths except: ≤420 nm wavelength (Black Light Lens), 500-570nm peak wavelengths (TransLume Green Lens) | | | Technical Specifications: Depth of Cure | 2mm | 2mm | Identical | | Recognized Standards | ISO 10650:2018 IEC 80601-2-60:2019 ISO 14971:2019 | ISO 10650:2018 IEC 80601-2-60:2019 ISO 14971:2007/(R)2010 | The additional standards used during the development of the | | | IEC 62366-1:2015 ISO 10993-1:2018 IEC 60601-1:2012 IEC 62471:2006 | IEC 62366-1:2015 ISO 10993-1:2018 | product reflect the standards applicable for the curing light alone. As the predicate submission, K210550, aimed at adding the additional VALO Accessory Lenses alone to a previously cleared VALO Grand Corded, K190627, these standards were not included in the submission but are currently applied to VALO Grand Corded. | | Parameters of Disinfection | VALO X: Disinfectant: 70% isopropyl alcohol (IPA) VALO X Accessory Lenses: Cleaners – Henry Schein General Purpose Cleaner or equivalent product Disinfectant - Cidex® OPA Solution or equivalent product | VALO Grand Corded: Acceptable Cleaners - Lysol Brand III Disinfectant Spray (Recommended) Cavicide products (non-bleach) Isopropyl alcohol Ethyl alcohol-based cleaners Lysol Concentrate (alcohol-based only) Accessory Lenses: Cleaners – Henry Schein General Purpose Cleaner or equivalent product Disinfectant - Cidex® OPA Solution or equivalent product | Validated disinfectant is used in place of acceptable cleaners | | User Interface | | | | | | VALO X has minimal user interface items, two buttons with visual indicators and an accelerometer function allowing mode changes by a drum tap and wave motion. | VALO Grand Corded has a moderate user interface system. On the device itself there are three buttons and a visual indicator system. | Both the subject and predicate devices use different button presses to control functions, audible cues to acknowledge mode change, and indicator lights to identify current mode selected and other state/ functions. The addition of the accelerometer function to the subject device aims to enhance the user interface by allowing a simplified method to change modes. | ### Table 5-1: VALO™ X and VALO™ X Accessory Lenses substantial equivalence comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ As outlined in the comparison tables above, VALO™ X and VALO™ X Accessory Lenses are similar to the identified predicate device with respect to intended user, materials, light intensity, depth of cure, utilized consensus standards, peak wavelength and biocompatibility. Primary differences between the subject device and predicate device are the option of using VALO X by means of batteries (cordless version) or AC power supply (corded version), the different operating modes (two curing modes and two diagnostic modes), the use of a bluelight blocking shield in place of blue-light blocking glasses, updated user interface with fewer buttons and the addition of an accelerometer function, the addition of a fourth whitewavelength LED, and the reliance on a validated disinfectant process rather than a list of acceptable cleaners. # VII. Performance Data Device design validation and verification activities have been performed to FDA Guidance Document "Dental Curing Lights - Premarket Notification [510(k)]" and recognized standards and via internal testing protocols. Software verification and validation of the device were conducted in accordance with the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Non-clinical tests performed to establish substantial equivalence to the identified predicate device included radiant exitance, illuminance and color temperature, beam profile, duty cycle, EMC, electromagnetic disturbance, photobiological safety and disinfection validation testing. See the table below for standards used during non-clinical testing. | ISO 10650:2018 | Dentistry - Powered polymerization activators | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 80601-2-60:2019 | Particular requirements for basic safety and essential performance of dental equipment | | ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing within risk management process | | IEC 60601-1:2012 | Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance | | IEC 60601-1-2:2014 | Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 62471:2006 | Photobiological safety of lamps and lamp systems | {12}------------------------------------------------ Conclusion: Based on these comparisons to the predicate device, we believe that VALO™ X and VALO™ X Accessory Lenses are substantially equivalent to the predicate device, in that they achieve the same intended use by similar technologies that do not raise new concerns of safety or efficacy.