(4 days)
Not Found
No
The summary describes a dental curing light and its accessories, focusing on light spectrum, power source, and physical design. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies listed are standard tests for a curing light, not AI/ML model validation.
No.
A therapeutic device is one that treats a disease or condition. This device is described as a source of illumination for curing photo-active materials and adhesives, and for aiding visualization during oral procedures. While it performs a function in dental procedures, it does not directly treat a disease or condition of the patient.
Yes
The device's intended use explicitly states "It is also intended to provide illumination to aid in visualization during oral procedures." Furthermore, several accessory lenses are described with "Diagnostic Aid Mode" for purposes like "accurate color/shade comparison," "visualization of fluorescing chemicals in dental resins," and "visualization of teeth and dental prostheses."
No
The device description clearly outlines a physical curing light with various accessory lenses, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- VALO X Function: The VALO X curing light is used directly on the patient's oral cavity to cure dental materials and aid in visualization during procedures. It does not analyze specimens taken from the body.
The device's intended use and description clearly indicate it's a dental device used for procedures within the mouth, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
EBZ, EAO, PEO
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:
- PointCure Lens: Augments the VALO X curing light to polymerize composite through a translucent prosthetic. (Curing Mode)
- ProxiCure Ball: Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration. (Curing Mode)
- Diffuser Lens: Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed. (White Light Diagnostic Aid Mode)
- Diffuser Lens: Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins. (Black Light Diagnostic Aid Mode)
- Interproximal Lens: Augments the VALO X curing light in visualization of teeth and dental prostheses. (White Light Diagnostic Aid Mode)
- Translume: Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses. (Curing or Diagnostic Aid Modes)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist or dental professional
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.
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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
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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
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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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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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. |
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| 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:
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| 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
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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 |
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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.