(39 days)
Not Found
No
The description focuses on hardware components (lamps, controllers) and software for controlling treatment parameters based on physician input, with no mention of AI/ML algorithms for analysis or decision-making.
Yes
The device is indicated for use to treat diagnosed skin disorders, such as psoriasis, vitiligo, and atopic dermatitis (eczema), under the direction of a physician. This clear therapeutic intent classifies it as a therapeutic device.
No
Explanation: The device is indicated for "therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders" and "to treat diagnosed skin disorders", meaning it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "full body medical ultraviolet device" that delivers treatment through an array of fluorescent lamps. While it utilizes software interfaces for control, the core medical device is a hardware-based phototherapy unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat diagnosed skin disorders using ultraviolet or visible radiation. IVD devices are used to diagnose diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
- Device Description: The device is a full-body medical ultraviolet device that delivers therapeutic treatment. It does not involve the analysis of biological samples.
- Anatomical Site: The treatment is applied topically to the skin, not to a biological specimen.
The device is a therapeutic device used for phototherapy, not a diagnostic device.
N/A
Intended Use / Indications for Use
The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
Product codes
FTC
Device Description
The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length).
Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface.
The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators.
Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001.
While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Topical skin treatment
Indicated Patient Age Range
Pediatric to Geriatric
Intended User / Care Setting
Hospital, Clinic, Medical Center, Private Medical Practice, or other Professional Medical environments under the direction of a physician.
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)
The 3 Series NeoLux device performance data is the same as or very similar to that of the claimed predicate devices. The lamps and construction used in the production of the predicate devices and the 3 Series NeoLux are the same. The devices materials, construction, treatment modality, patient safety, etc., is exactly the same or similar.
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
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.
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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 24, 2023
Daavlin Distributing Co. Michele Thiel Regulatory Manager 205 West Bement Street Bryan, Ohio 43506
Re: K230382
Trade/Device Name: 3 Series NeoLux Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: March 16, 2023 Received: March 16, 2023
Dear Michele Thiel:
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,
Jessica Carr -S
for Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230382
Device Name 3 Series NeoLux
Indications for Use (Describe)
The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K230382 510(k) Summary
| 510(K) Summary: | ||
|---|---|---|
| ----------------- | -- | -- |
| Date of Summary: | March 23, 2023 |
|---|---|
| 510(k) Submitter: | Daavlin Distributing Company |
| Contact Person: | Michele Thiel |
| Regulatory Manager | |
| Daavlin Distributing Company | |
| 205 West Bement Street | |
| Bryan, Ohio 43506 | |
| Phone: (419) 636-6304 Ext. 207 | |
| Fax: (419) 636-1739 | |
| Email: mthiel@daavlin.com | |
| Trade Name: | 3 Series NeoLux |
| Common Name: | Phototherapy Equipment |
| 510(k) Number: | K230382 |
| Regulation Number: | 21 CFR 878.4630 |
| Classification Name: | Ultraviolet lamp for dermatologic disorders |
| Device Class: | Class II |
| Product Code: | FTC |
| Panel: | General and Plastic Surgery |
| Predicate Devices: | 3 Series Phototherapy Unit (K153749) |
| M Series Phototherapy Equipment (K210881) | |
| 510(k) Numbers: | K153749, K210881 |
| Company: | Daavlin Distributing Company |
4
| Device Description: | The 3 Series NeoLux device is a full body medical ultraviolet device,
which is intended for use, by or under the direction of a physician, for
therapeutic treatment for individuals who require ultraviolet or visible
radiation for diagnosed skin disorders.
The 3 Series NeoLux device delivers a 360-degree full body
treatment, with spectral output from UV through visible, through an
array of 24-48 fluorescent lamps (Either F72 or F79 length).
Treatments are controlled through the Smart Touch Controller
Software interface, Flex Controller or ClearLink Controller interface.
The Smart Touch Software interface is installed remotely on a
custom-built computer. An "off the shelf" replacement is not possible.
Replacement can only be obtained through Daavlin. Access to the
interface and stored information is restricted to individuals who have
been established by the physician as authorized operators.
Furthermore, the physician can restrict the amount and type of access
that is granted to each authorized operator. Each authorized operator is
assigned an initial default pin number. The system requires each
operator to select a new individual pin and change the default pin
upon initial logon. Authorized operators program treatments in joules
based on established treatment protocols governed by the patient's
skin type, condition, minimum erythemal dose (M.E.D.), and
treatment frequency. The Smart Touch equipped computer will
interface with the 3 Series NeoLux device through a closed wired
Ethernet connection and a Daavlin Distributing Company UV4001.
While the Flex Controller is controlled by an integrated digital timer
with an LCD segmented display and four membrane buttons as the
interface, and ClearLink Controller is controlled by a microprocessor
controlled with an LCD touch screen display. When the operator sets
the treatment time or the desired dose using the operator interface
located on the control panel, the treatment begins by illuminating the
lamps which emit the prescribed light. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The 3 Series Neolux devices are indicated for use to treat diagnosed
skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic
dermatitis (eczema) under the direction of a physician. The
population may range from pediatric to geriatric. |
| Intended Use: | The 3 Series Neolux devices are intended to be used as full body
therapeutic devices. They are designed to be used under the direction
of a physician for individuals who require phototherapy. |
| Predicate
Comparison: | The 3 Series NeoLux device is constructed in the same design
configuration as the predicate devices, utilizing identical energy
sources and materials of identical or similar composition. The spectral
output, mode of operation, labeling, treatment area, treatment
modality, patient safety, and general operating principals of the 3
Series NeoLux device is the same or similar to those of the predicate
devices. |
5
| Features | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| 3 Series NeoLux | |||
| Phototherapy | |||
| Equipment | 3 Series NeoLux | ||
| Phototherapy Unit | M Series | ||
| Phototherapy | |||
| Equipment | |||
| 510(k) Number | This Submission | ||
| K230382 | K153749 | K210881 | |
| Picture | Image: 3 Series NeoLux Phototherapy Equipment | Image: 3 Series NeoLux Phototherapy Unit | Image: M Series Phototherapy Equipment |
| Features | Subject Device | ||
| 3 Series NeoLux | |||
| Phototherapy | |||
| Equipment | Predicate Device | ||
| 3 Series NeoLux | |||
| Phototherapy Unit | Predicate Device | ||
| M Series | |||
| Phototherapy | |||
| Equipment | |||
| 510(k) Number | This Submission | ||
| K230382 | K153749 | K210881 | |
| Indications for | |||
| Use | The 3 Series Neolux | ||
| devices are indicated | |||
| for use to treat | |||
| diagnosed skin | |||
| disorders such as, but | |||
| not limited to, | |||
| psoriasis, vitiligo, and | |||
| atopic dermatitis | |||
| (eczema) under the | |||
| direction of a | |||
| physician. The | |||
| population may range | |||
| from pediatric to | |||
| geriatric. | The 3 Series NeoLux is | ||
| a full body ultraviolet | |||
| emitting medical light | |||
| source, which is | |||
| intended for use by or | |||
| under the direction of a | |||
| licensed physician for | |||
| the treatment of | |||
| psoriasis, vitiligo, and | |||
| atopic dermatitis | |||
| (eczema) on all skin | |||
| types (I-VI). | The M Series | ||
| Phototherapy | |||
| Devices are indicated | |||
| for use to treat | |||
| diagnosed skin | |||
| disorders such, as but | |||
| not limited to, | |||
| psoriasis, vitiligo, | |||
| and atopic dermatitis | |||
| (eczema) under the | |||
| direction of a | |||
| physician. The | |||
| physician will | |||
| determine the light | |||
| spectrum (ultraviolet | |||
| to visible), the | |||
| energy or duration of | |||
| the treatment, as well | |||
| as the treatment | |||
| environment. | |||
| The population may | |||
| range from pediatric, | |||
| when accompanied by a | |||
| responsible adult to | |||
| operate it, to geriatric. | |||
| Prescriptive | Yes | Yes | Yes |
| Patient | |||
| Population | Pediatric to Geriatric | Pediatric to Geriatric | Pediatric to Geriatric |
| Patient | |||
| Contact | There is no direct | ||
| patient contact with the | |||
| device during treatment | |||
| – Areas of skin are | |||
| exposed to controlled | |||
| ultraviolet radiation | |||
| from a distance of | |||
| approximately 9 inches | |||
| (22.86 cm) away. | There is no direct | ||
| patient contact with the | |||
| device during treatment |
- Areas of skin are
exposed to controlled
ultraviolet radiation
from a distance of
approximately 9 inches
(22.86 cm) away. | Patient comes in direct
contact with the acrylic
when placing hands or
feet inside for
treatment. |
| Anatomical
Sites | Topical skin treatment | Topical skin treatment | Topical skin treatment |
| Features | Subject Device | Predicate Device | Predicate Device |
| | 3 Series NeoLux | 3 Series NeoLux | M Series |
| | Phototherapy
Equipment | Phototherapy Unit | Phototherapy
Equipment |
| 510(k) Number | This Submission
K230382 | K153749 | K210881 |
| Application
Environment | Hospital, Clinic,
Medical Center, Private
Medical Practice, or
other Professional
Medical environments
under the direction of a
physician. | Hospital, Clinic,
Medical Center, Private
Medical Practice, or
Other Professional
Medical Environments
under direction of
physician | Hospital, Clinic,
Medical Center, Private
Medical Practice, or
other environment
under the direction of a
physician. |
| Materials | Interior: Assembles
components, ballasts,
electronics housed in a
metal frame with
reflective internal
surfaces, fluorescent
lamps, and protective
acrylic. | Interior: Assembles
components, ballasts,
electronics housed in a
metal frame with
reflective internal
surfaces, fluorescent
lamps, and protective
acrylic. | Assembled components
housed in metal frame
with reflective internal
surfaces and
fluorescent lamps |
| Manufacturing
Methods | Identical | Identical | Identical |
| Number of
Lamps | 24 - 48 | 24 - 48 | 8 |
| Lamp
Spectrums | UV through Visible | UV through Visible | UV through Visible |
| Treatment
Area | Full Body | Full Body | Partial Body |
| Patient
Cooling | Fan | Fan | Ambient |
| Power Output
(mW/cm2) | 5 – 254 | 5 – 255 | 2.9- 17.46 |
| Controller | ClearLink Controller
Flex Controller
SmartTouch Controller | Flex Controller
SmartTouch Controller | ClearLink Controller
SmartTouch Controller |
6
7
4 Power output is dependent on number of lamps at 9".
Power output is dependent on number of lamps at 9".
« Power output is dependent on number of lamps at 0".
8
| Performance Standards: | The 3 Series NeoLux device performance data is the same as or
very similar to that of the claimed predicate devices. The lamps and
construction used in the production of the predicate devices and the
3 Series NeoLux are the same. The devices materials, construction,
treatment modality, patient safety, etc., is exactly the same or
similar. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | On the basis of the information provided in this Summary, the
Daavlin Distributing Company believes the 3 Series NeoLux device
is substantially equivalent to the legally commercialized predicate
devices. |