(69 days)
Not Found
No
The summary describes a phototherapy device using a UV-B excimer lamp for targeted treatment of skin conditions. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or other sections. The predicate devices are also phototherapy systems without apparent AI/ML components.
Yes
The device is used for phototherapy to treat skin conditions, which is a therapeutic application.
No
The device description states it "emits targeted (ultra-narrow) ultraviolet wavelength... effective for the treatment of skin conditions," indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength" and mentions a "XeCl excimer lamp inside a handpiece," indicating it is a hardware device that emits UV-B light.
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 VTRAC Excimer Lamp System is a phototherapy device that applies UV-B light directly to the skin for treatment. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the treatment of skin conditions, not for diagnosis based on in vitro analysis.
Therefore, the device described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Product codes
GEX
Device Description
The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) The v TV to Lawner Dailip 375th to a that emits targeted (ultra-narrow) ultraviolet wavelength a that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which that is meradees in the O Pective for the treatment of skin conditions that respond favorably to illas occh decemined to creceive for and available UV-B phototherapy. UNB-UVB is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that a ACCI exoment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.
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)
K024020, K022165, K020591, K021762, K040062
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
AUG 9 - 2005
510(k) Summary of Safety and Effectiveness STO(K) Summary of Salety and Encellier Lamp System KOS (Y A 8
1. GENERAL
| • Submitter (Applicant): | PhotoMedex, Inc.
147 Keystone Drive
Montgomeryville, PA, 18936 |
| -------------------------- | ---------------------------------------------------------------------- |
|---|
- Bob Rose (760) 602-3300 Contact Person: .
- July 7, 2005 Date Prepared: .
2. DEVICE NAME
- Ultraviolet lamp for dermatologic disorders; 21 CFR Classification name: . 8878.4630 - Class II
- Common or usual name: Targeted (localized) UVB Excimer Lamp Phototherapy . System
- Trade or proprietary name: VTRAC Excimer Lamp System .
3. LEGALLY MARKETED PREDICATE DEVICES
TheraLight UV120-2 UVA / UVB Phototherapy System Cleared via K024020 and K022165
Lumenis BClear™ Cleared via K020591 and K021762
Levia Phototherapy System Cleared via K040062
4. DEVICE DESCRIPTION
The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) The v TV to Lawner Dailip 375th to a that emits targeted (ultra-narrow) ultraviolet wavelength a that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which that is meradees in the O Pective for the treatment of skin conditions that respond favorably to illas occh decemined to creceive for and available UV-B phototherapy. UNB-UVB is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that a ACCI exoment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.
XVI- 2
1
5. INDICATIONS FOR USE
UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.
SUBSTANTIAL EQUIVALENCE 6.
The intended use for the VTRAC Excimer Lamp System is similar to the predicate devices identified in that the wavelength, energy, indicated used and safety considerations are within the current applications of UV-B phototherapy, or supported by published clinical data included in this application.
PhotoMedex believes the introduction of the VTRAC Excimer Lamp System poses no new issues of safety and is similar in intended use as compared to the predicates identified within this application.
7. SAFETY AND EFECTIVENESS; PRODUCT PERFORMANCE
The VTRAC Excimer Lamp System is designed, tested and are to be manufactured in accordance with both mandatory and voluntary standards, including 21 CFR PART 820 the Quality System Regulation, EN60601-1, EN60601-1-2, EN 60601-1-4, EN ISO 14971, and UL2601-1 / UL60601-1. The inclusion of these standards will further ensure when the VTRAC Excimer Lamp System is used according to the instructions for use, that it is both safe and effective for the applications indicated.
8. CONCLUSIONS
Based on the information reviewed and provided within this application, PhotoMedex believes that the VTRAC Excimer Lamp System is substantially equivalent to the TheraLight UV120-2 UVA / UVB Phototherapy System, the Lumenis BClear™, and the Levia Phototherapy System, in that it is safe and effective as the legally marketed predicate devices, and that they share similar mechanisms for laser energy delivery and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus. The caduceus is depicted with four curved lines representing snakes or streams, and the text is in a simple, sans-serif font.
AUG 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bob Rose Director of Regulatory Affairs ... . . and Quality Assurance PhotoMedex, Inc. 147 Keystone Drive Montgomeryville, Pennsylvania 18936
Re: K051428
Trade/Device Name: VTRAC Excimer Lamp System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: GEX Dated: May 27, 2005 Received: June 1, 2005
Dear Mr. Rose:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreament date of the Medical Device Amendments, or to conniver provise 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 r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is elabsined (600 wor of ols. Existing major regulations affecting your device can may be subject to date al 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 or any 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.
3
Page 2- Mr. Bob Rose
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notheation. The PDA midning of backership 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 (2) CFR Part 801), please If you desire specific advice for your as not 100 hose note the regulation entitled, Contact the Office of Comptance at (210) = 16 = 16 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 = = = "Misbranding by reference to premanteenthilities under the Act from the Division of Small other general information on your responsible in the same 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,
Barbara buchu
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051428 ﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
r
Device Name:
VTRAC Excimer Lamp System
Indications For Use:
UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis and leukoderma.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(ODE) Concurrence of GB. Civision of General, Restorative 11d Neurological Devices
Number 5051428