Who is the manufacturer of 3 Series NeoLux?

Daavlin Distributing Co. filed the 510(k) submission for 3 Series NeoLux (K230382).

What is the FDA product code for 3 Series NeoLux?

FTC. It is classified under 21 CFR 878.4630 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for 3 Series NeoLux?

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

Who can help prepare an FDA 510(k) submission like 3 Series NeoLux?

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.

3 Series NeoLux

Q: What are the predicate devices for 3 Series NeoLux?

3 Series Phototherapy Unit (K153749); M Series Phototherapy Equipment (K210881).

K230382 · Daavlin Distributing Co. · FTC · Mar 24, 2023 · General, Plastic Surgery

Device Facts

Record ID	K230382
Device Name	3 Series NeoLux
Applicant	Daavlin Distributing Co.
Product Code	FTC · General, Plastic Surgery
Decision Date	Mar 24, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4630
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

3 Series NeoLux is a full-body medical ultraviolet phototherapy device used in hospitals, clinics, and private medical practices. It delivers 360-degree UV through visible radiation using an array of 24-48 fluorescent lamps. Operated by authorized personnel under physician direction, the device is controlled via the Smart Touch Controller (remote computer interface), Flex Controller (integrated digital timer), or ClearLink Controller (microprocessor-controlled touch screen). Operators program treatments in joules based on patient skin type, condition, and minimum erythemal dose (M.E.D.). The system ensures safety through PIN-restricted access and controlled exposure. By delivering precise, physician-prescribed light doses, the device aids in managing dermatologic conditions, potentially improving patient skin health.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and performance characteristic comparisons to legally marketed predicate devices.

Technological Characteristics

Full-body phototherapy unit; 24-48 fluorescent lamps (F72 or F79); spectral output UV through visible; metal frame construction with reflective internal surfaces and protective acrylic; fan cooling; wired Ethernet connectivity for Smart Touch Controller; power output 5–254 mW/cm2.

Indications for Use

Indicated for treatment of diagnosed skin disorders including psoriasis, vitiligo, and atopic dermatitis (eczema) in patients ranging from pediatric to geriatric, under physician direction.

Regulatory Classification

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.

Predicate Devices

3 Series Phototherapy Unit (K153749)
M Series Phototherapy Equipment (K210881)

Related Devices

K153749 — 3 Series Phototherapy Unit · Daavlin Distributing Company · Jun 30, 2016
K210881 — M Series Phototherapy Equipment · Daavlin Distributing Co. · Jun 22, 2021
K151795 — ML24000 UVA-1 Phototherapy Cabinet · Daavlin Distributing Co. · Sep 10, 2015
K212510 — 7 Series Phototherapy Device · Daavlin Distributing Co. · Nov 4, 2021
K050695 — FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT · Daavlin Distributing Co. · Apr 19, 2005

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 & 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) | | |-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE I NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED ORM TO THE PRA STA 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}------------------------------------------------ ## 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. |