(42 days)
Philips TL100W/01 UV-B
Not Found
No
The device description focuses solely on the technical specifications of UV-B lamps and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as having an intended function of "therapy for Psoriasis and Vitiligo", which directly indicates its use as a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is "therapy for Psoriasis and Vitiligo," which indicates a therapeutic purpose, not a diagnostic one.
No
The device description clearly lists physical hardware components (UV-B lamps with specific wattage, voltage, base, and dimensions), indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The stated intended use is "therapy for Psoriasis and Vitiligo." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a UV-B lamp, which is a light source used for treatment, not for analyzing samples from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This UV-B lamp does not fit that description.
N/A
Intended Use / Indications for Use
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vitiligo.
Product codes
FTC
Device Description
Philips TL20W/01/RS UV-B
Watts - 20
Volts - 57
Base - G13
Bulb - T12
Length - max 604mm pin end to pin end
Philips PL-S 9W/01/2P UV-B
Watts - 9
Volts - 60
Base - G23
Length - max OAL - 167 mm
Philips PL-L 36W/01/4P UV-B
Watts - 36
Volts - 105
Base - 2G11
Length - max OAL - 417 mm
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Philips TL100W/01 UV-B
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/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield is a globe with horizontal and vertical lines, and a wavy line across the middle. There is also a star at the bottom of the globe.
Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name. The image is clear and easy to read.
Philips Lighting Company
MAY 1 6 2002
510K SUMMARY STATEMENT
| Company Name: | Philips Lighting Company
200 Franklin Square Drive
Somerset, NJ 08875-6800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Toni J. Hoffmann
Corporate Quality Analyst |
| Telephone: | 732-563-3081 |
| Trade Names: | Philips TL20W/01/RS UV-B
Philips PL-S 9W/01/2P UV-B
Philips PL-L 36W/01/4P UV-B |
| Common Name: | UVB Lamps |
| Classification: | Light, Ultraviolet, Dermatological |
| Description: | Philips TL20W/01/RS UV-B
Watts - 20
Volts - 57
Base - G13
Bulb - T12
Length - max 604mm pin end to pin end
Philips PL-S 9W/01/2P UV-B
Watts - 9
Volts - 60
Base - G23
Length - max OAL - 167 mm
Philips PL-L 36W/01/4P UV-B
Watts - 36
Volts - 105
Base - 2G11
Length - max OAL - 417 mm |
| Intended Use: | The intended function of the UV-B ultraviolet lamp is therapy for
Psoriasis and Vitiligo. |
| Equivalence: | Substantial equivalence previous devices. Lamps are different
dimensionally but have substantially equivalent outputs to Philips
TL100W/01 UV-B |
Ref: FDA-510K Summary Statement File: 14.01.23
Image /page/0/Picture/8 description: The image shows the ISO 9001 KEMA CERT logo. The logo includes the text "ISO 9001" in bold letters above the text "KEMA CERT". Below this, there are two accreditation statements, though the text is too small to read clearly. The logo is black and white and appears to be part of a larger document.
200 Franklin Square Drive P.O. Box 6800
Somerset, NJ 08875-6800
Tel: (732) 563-3000
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MAY 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Toni Hoffmann Corporate Quality Analyst Philips Lighting Company 200 Franklin Square Drive Somerset. NJ 08875-6800
Re: K021092
Trade/Device Name: Philips TL20W/01/RS UV-B Philips PL-S 9W/01/2P UV-B Philips PL-L 36W/01/4P UV-B
Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: March 7, 2002 Received: April 4, 2002
Dear Ms. Hoffman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in 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.
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Page 2 - Ms. Toni Hoffmann
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. The word appears to be a logo or brand name, and the image is likely a close-up of the wordmark.
Philips Lighting Company
INDICATION FOR USE STATEMENT
510(k) Number (if known): K021092
Philips TL20W/01/RS UV-B Device Names: Philips PL-S 9W/01/2P UV-B Philips PL-L 36W/01/4P UV-B
The intended function of the UV-B ultraviolet lamp is therapy for Psoriasis and Vittiligo.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Miriam C. Provost
- Restorative
OR
021092
Prescription Use (Per 21 CRF 8001.109)
Image /page/3/Picture/12 description: The image shows a logo for ISO 9001 certification. The logo includes the text "ISO 9001" in bold, black letters. Below the text, it says "KEMA CERT" in smaller letters. There is also some text below that, but it is too blurry to read.
A division of Philips Electronics North America Corporation
510(k) Number
200 Franklin Bq P.O. Box 6800 Somerser, NJ 08875-680 Tel: (732) 563-3000
(Optional Format 1-2-96)
Over-the-Counter Use
Ref: FDA Indication Use Statement