(86 days)
Not Found
No
The description focuses on the laser technology and hardware components, with no mention of AI or ML terms, image processing, or data training/testing.
Yes
The device explicitly describes its intended use for "UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma," which are medical treatments for diseases, thus qualifying it as a therapeutic device.
No
The device description indicates it is a "UVB Phototherapy" system used for treatment of skin conditions, not for diagnosis. It generates UV light at a specific wavelength for therapeutic purposes.
No
The device description explicitly details hardware components such as a laser light source, fiberoptic delivery system, handpiece, foot-switch, and protective housing, indicating it is a physical medical device, not software-only.
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 Description: The description clearly states that the XTRAC XL Plus Excimer Laser Phototherapy System is a "UV laser light source" used for "UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma." This is a therapeutic device that applies light directly to the skin.
- Lack of Biological Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device directly interacts with the patient's skin.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
targeted skin
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)
Testing conducted on the XTRAC XL Plus Excimer Laser Phototherapy System includes conformance to all relevant international EN 60601 series of standards and applicable laser Performance Standards (21 CFR Part 1040.10 & 1040.11), as well as UL 2601.
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.
K992914, K003705, K011382, K020847
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
§ 878.4810 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.
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AUG - 1 2003
Ko31451
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"Special 510(k): Device Modification" XTRAC Excimer Laser, AL7000
510(k) SUMMARY PhotoMedex, Inc. XTRAC XL Plus Excimer Laser System, model AL 7000
1. GENERAL
| • Submitter: | PhotoMedex, Inc.
2431 Impala Drive
Carlsbad, CA 92008 |
| -------------- | ------------------------------------------------------------- |
|---|
- Contact Person: Bob Rose .
- May 5, 2003 Date Prepared: ●
2. DEVICE NAME
- Classification name: (21 CFR $878.4810; Laser Surgical Instrument for use in . General and Plastic Surgery and Dermatology
- Common or usual name: XeCl excimer laser .
- . Trade or proprietary name: XTRAC XL Plus Excimer Laser System, model AL 7000
3. PREDICATE DEVICES
Excimer Laser
- XTRAC Excimer Laser System, model AL7000 ● Photomedex, Inc. 510(k) numbers: K992914, K003705, K011382 & K020847
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31451 2/2
"Special 510(k); Device Modification" XTRAC Excimer Laser, AL7000
4. DEVICE DESCRIPTION
The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.
5. INTENDED USE
The intended use is UVB phototherapy of targeted skin for treatment psoriasis, vitiligo, atopic dermatitis and leukoderma.
6. SUBSTANTIAL EQUIVALENCE
Current published data supports 308 nm UVB to be effective of providing efficacy to the currently approved indications for use, which the AL7000 has been previously cleared for.
The intended use for the PhotoMedex XTRAC XL Plus Excimer Laser System is within the scope of the predicate device, the current market cleared PhotoMedex AL7000 excimer laser phototherapy system. Both device types share the same methods and mechanisms to produce targeted and controlled doses of UV light to affected target areas.
The XTRAC Excimer Laser System, model AL7000 is market cleared per 510(k) numbers K992914. K003705. K011382. & K020847 for the treatment of psoriasis, viuiligo, atopic dermatitis and leukoderma.
7. PRODUCT PERFORMANCE TESTING
Testing conducted on the XTRAC XL Plus Excimer Laser Phototherapy System includes conformance to all relevant international EN 60601 series of standards and applicable laser Performance Standards (21 CFR Part 1040.10 & 1040.11), as well as UL 2601.
8. CONCLUSIONS
Based on the intended use, the previously cleared technological characteristics of the AL7000, and the performance data documented to support the modifications, PhotoMedex believes that the XTRAC XL Plus Excimer Laser Phototherapy System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Mr. Bob Rose Director of RA/QA PhotoMedex, Inc. 2431 Impala Drive Carlsbad, California 92008
Re: K031451
Trade/Device Name: XTRAC XL Plus Excimer Laser System, Model AL7000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 5, 2003 Received: May 15, 2003
Dear Mr Rose:
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 - Mr. Bob Rose
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), 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) you may obtain. 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/dsmamain.html
Sincerely yours,
Miriam C. Provost
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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"Special 510(k): Device Modification" XTRAC Excimer Laser. AL7000
510(k) Number (if known): 《س½½½ /
Device Name:
XTRAC XL Plus Excimer Laser System, model AL 7000
Indications for Use:
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031451