3 Series Phototherapy Unit

K153749 · Daavlin Distributing Company · FTC · Jun 30, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K153749
• Device Name: 3 Series Phototherapy Unit
• Applicant: Daavlin Distributing Company
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

Device Story

3 Series NeoLux is a full-body medical ultraviolet cabinet for dermatologic disorders; delivers 360-degree treatment via 24-48 fluorescent lamps (311 nm Narrow Band UVB and/or 350 nm UVA). Used in hospitals, clinics, and private medical practices under physician direction. Operators use 'Soft Touch Software' to program treatment doses in joules based on patient skin type, condition, and minimum erythemal dose (M.E.D.). Device provides controlled UV radiation exposure from approximately 9 inches away; no direct patient contact. Output helps clinicians manage skin conditions; benefits patients through therapeutic UV radiation.

Clinical Evidence

Bench testing only. Performance data demonstrates conformance to IEC 60601-1:2012 (Safety), IEC 60601-1-2:2007 (EMC), and IEC 60601-2-57:2011. No clinical data presented.

Technological Characteristics

Full-body cabinet; metal frame with reflective internal surfaces; 24-48 fluorescent lamps (UVB/UVA); spectral output 280-400 nm. Dimensions: 83.6" x 41.4" x 39.3". Power: 208-240V, 60Hz, 100A. Software-controlled interface. Protective acrylic lamp covering. No direct patient contact.

Indications for Use

Indicated for treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in pediatric to geriatric patients of all skin types (I-VI).

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 SP/PC Phototherapy Unit (K063621)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2016

Daavlin Distributing Company Ms. Michele Thiel Management Representative 205 West Bement Street Bryan, Ohio 43506

Re: K153749

Trade/Device Name: 3 Series Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 1, 2016 Received: June 1, 2016

Dear Ms. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K153749

Device Name

3 Series NeoLux Phototherapy Unit

#### Indications for Use (Describe)

The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

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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# K. 510(k) Summary

| Date of Summary: | December 14, 2015 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Submitter: | Daavlin Distributing Company | |
| Contact Person: | Michele Thiel<br>Management Representative<br>Daavlin Distributing Company<br>205 West Bement Street<br>P.O. Box 626<br>Bryan, Ohio 43506<br>Phone: [phone] Ext. 207<br>Fax: [phone]<br>Email: [e-mail] | |
| Trade Name: | 3 Series NeoLux Phototherapy Unit | |
| Common Name | Ultraviolet Full Body Phototherapy Unit | |
| 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 Device: | 3 Series SP/PC Phototherapy Unit | |
| 510(k) Number: | K063621 | |
| Product Code: | FTC | |
| Company: | Daavlin Distributing Company | |

្រពួក ប

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The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is Device Description: intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps.

> Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. 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.

Indications for Use: The 3 Series NeoLux. full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

Predicate Comparison: The 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC device are identical in nearly every aspect. Both the 3 Series NeoLux and the 3 Series SP/PC device are constructed using identical manufacturing methods, quality control operations, and are comprised of materials, components, and subassemblies which are identical or very similar in construction and composition. The 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC device feature the same indications for use, patient population, application environment, lamp types, spectral output, labeling, treatment area, electrical requirements, and ventilation requirements. As previously stated the only difference between the 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC predicate device are changes in exterior cosmetics and lamp covering. Beyond this modification there has been no other changes between the 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC predicate device

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| Features | Subject Device<br>3 Series NeoLux Phototherapy Unit | Predicate Device<br>3 Series SP/PC Phototherapy Unit |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | This Submission | K063621 |
| Indications for Use | The 3 Series NeoLux is a full body<br>ultraviolet emitting medical light source,<br>which is intended for use by or under the<br>direction of a licensed physician for the<br>treatment of psoriasis, vitiligo, and<br>atopic dermatitis (eczema) on all skin<br>types (I-VI). | The 3 Series PC & SP, full body phototherapy<br>device, is a medical ultraviolet cabinet, which<br>is itended for the treatment of psoriasis,<br>vitiligo, and atopic dermatitis (eczema) on all<br>skin types (I-VI) |
| Prescriptive | Yes | Yes |
| Patient Population | Pediatric to Geriatric | Pediatric to Geriatric |
| Patient Contact | There is no direct patient contact with<br>the device during treatment - Areas of<br>skin are exposed to controlled<br>ultraviolet radiation from a distance of<br>approximately 9 inches (22.86 cm) away. | There is no direct patient contact with the<br>device during treatment - Areas of skin are<br>exposed to controlled ultraviolet radiation<br>from a distance of approximately 9 inches<br>(22.86 cm) away. |
| Anatomical Sites | Full Body | Full Body |
| Application<br>Environment | Hospital, Clinic, Medical Center, Private<br>Medical Practice, or Other Professional<br>Medical Environments under direction<br>of physician | Hospital, Clinic, Medical Center, Private<br>Medical Practice, or Other Professional<br>Medical Environments under direction of<br>physician |
| Dimensions | Height : 83.6" (212.3cm) Width : 41.4"<br>(104.4 cm) Depth : 39.3" (99.8 cm) | Height : 84" (213cm) Width : 42" (106 cm)<br>Depth : 41" (104 cm) |
| Power | 208-240V, 60Hz, 100A | 208-240V, 60Hz, 100A |
| Ventilation<br>Requirements | Minimum: XXX cfm<br>Desired: XXX cfm | Minimum: XXX cfm<br>Desired: XXX cfm |
| Spectral Output | 280-400 nm | 280-400 nm |
| Materials | Interior: Assembles components,<br>ballasts, electronics housed in a metal<br>frame with reflective internal surfaces,<br>fluorescent lamps, and protective<br>acrylic.<br>Exterior: Metal and Plastic Casing | Interior: Assembles components, ballasts,<br>electronics housed in a metal frame with<br>reflective internal surfaces, fluorescent lamps<br>and protective metal grids.<br>Exterior: Metal and Plastic Casing |
| Lamp Quantity | Up to 48<br>F72 or F79<br>UVB or UVA | Up to 48<br>F72<br>UVB or UVA |
| Manufacturing<br>Methods | Identical | Identical |

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| Performance Standards: | The 3 Series NeoLux Phototherapy Unit performance data is the same as or very<br>similar to that of the claimed predicate device. The ultraviolet lamps and cabinet<br>construction used in the production of the predicate device and the 3 Series NeoLux<br>Phototherapy Unit are the same. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Testing: | Performance testing for conformance to IEC 60601-1-2:2007; IEC 60601-1:2012; IEC<br>60601-2-57:2011 EMC and Safety. |
| Conclusion: | In summary, the 3 Series NeoLux Phototherapy Unit described in this submission is,<br>in our opinion, substantially equivalent to the legally commercialized unmodified<br>predicate device. |

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