(184 days)
Not Found
No
The description focuses on the physical device, lamp technology, and software interface for controlling treatment parameters based on physician-established protocols, with no mention of AI or ML capabilities.
Yes
The device is described as a "full body phototherapy device" intended for the "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)," indicating its purpose is therapeutic intervention for medical conditions.
No
The device is described as a "full body phototherapy device" intended for "therapeutic treatment" of diagnosed skin disorders using ultraviolet radiation, and does not mention any diagnostic capabilities.
No
The device description clearly states it is a "full body medical ultraviolet device" and a "medical ultraviolet cabinet" that delivers treatment through "an array of 24-48 fluorescent lamps." This indicates a physical hardware device, not software only. While it mentions a "Soft Touch Software interface," this software controls the hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 3 Series NeoLux is a phototherapy device that uses ultraviolet radiation to treat skin conditions directly on the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states treatment of skin conditions like psoriasis, vitiligo, and atopic dermatitis.
- Device Description: The description details a cabinet with UV lamps for direct application of light to the patient.
Therefore, the 3 Series NeoLux is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The 3 Series NeoLux Phototherapy Unit 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Full Body
Indicated Patient Age Range
Pediatric to Geriatric
Intended User / Care Setting
Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of 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 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet lamps and cabinet construction used in the production of the predicate device and the 3 Series NeoLux Phototherapy Unit are the same.
Performance testing for conformance to IEC 60601-1-2:2007; IEC 60601-1:2012; IEC 60601-2-57:2011 EMC and Safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
K. 510(k) Summary
| Date of Summary: | December 14, 2015 | |
|---|---|---|
| 510(k) Submitter: | Daavlin Distributing Company | |
| Contact Person: | Michele Thiel | |
| Management Representative | ||
| Daavlin Distributing Company | ||
| 205 West Bement Street | ||
| P.O. Box 626 | ||
| Bryan, Ohio 43506 | ||
| Phone: (419) 636-6304 Ext. 207 | ||
| Fax: (419) 636-1739 | ||
| Email: mthiel@daavlin.com | ||
| 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
4
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
5
| Features | Subject Device
3 Series NeoLux Phototherapy Unit | Predicate Device
3 Series SP/PC Phototherapy Unit |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | This Submission | K063621 |
| Indications for Use | 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 3 Series PC & SP, full body phototherapy
device, is a medical ultraviolet cabinet, which
is itended for the treatment of psoriasis,
vitiligo, and atopic dermatitis (eczema) on all
skin types (I-VI) |
| Prescriptive | Yes | Yes |
| Patient Population | 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. |
| Anatomical Sites | Full Body | Full Body |
| Application
Environment | 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 Professional
Medical Environments under direction of
physician |
| Dimensions | Height : 83.6" (212.3cm) Width : 41.4"
(104.4 cm) Depth : 39.3" (99.8 cm) | Height : 84" (213cm) Width : 42" (106 cm)
Depth : 41" (104 cm) |
| Power | 208-240V, 60Hz, 100A | 208-240V, 60Hz, 100A |
| Ventilation
Requirements | Minimum: XXX cfm
Desired: XXX cfm | Minimum: XXX cfm
Desired: XXX cfm |
| Spectral Output | 280-400 nm | 280-400 nm |
| Materials | Interior: Assembles components,
ballasts, electronics housed in a metal
frame with reflective internal surfaces,
fluorescent lamps, and protective
acrylic.
Exterior: Metal and Plastic Casing | Interior: Assembles components, ballasts,
electronics housed in a metal frame with
reflective internal surfaces, fluorescent lamps
and protective metal grids.
Exterior: Metal and Plastic Casing |
| Lamp Quantity | Up to 48
F72 or F79
UVB or UVA | Up to 48
F72
UVB or UVA |
| Manufacturing
Methods | Identical | Identical |
لمقاربة الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو
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్రామంలో గ్రామం
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6
| Performance Standards: | The 3 Series NeoLux Phototherapy Unit performance data is the same as or very
similar to that of the claimed predicate device. The ultraviolet lamps and cabinet
construction used in the production of the predicate device and the 3 Series NeoLux
Phototherapy Unit are the same. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical Testing: | Performance testing for conformance to IEC 60601-1-2:2007; IEC 60601-1:2012; IEC
60601-2-57:2011 EMC and Safety. |
| Conclusion: | In summary, the 3 Series NeoLux Phototherapy Unit described in this submission is,
in our opinion, substantially equivalent to the legally commercialized unmodified
predicate device. |
్రాలు మూలాలు
రించబడినవి విద్యాల ప్రాథమిక ప్రా
阿拉斯
الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق
The Court in the
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤ
ે. જુવિલુલ ગુજરાત રાજ્યના
ri