(62 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML capabilities. The performance study describes a clinical trial, not the training or testing of an AI/ML model.
Yes
The device is described as "UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma," which are conditions that require medical treatment. The description clearly states its purpose is to treat or alleviate these medical conditions.
No
The device is described as a phototherapy system used for treatment (UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma), not for diagnosing conditions.
No
The device description explicitly details hardware components such as a laser light source, fiberoptic delivery system, handpiece, footswitch, and protective housing. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma." This describes a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device is a "UV laser light source" that delivers light to the affected skin. This is a physical treatment modality.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological specimens.
The device is a therapeutic device used for phototherapy, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
The intended use is targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and non-autoimmune based leukoderma of affected skin.
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Product codes
GEX
Device Description
The XTRAC Excimer Laser System is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate an operator selected doseand 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 footswitch. 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
affected 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)
Verification and validation to substantiate inclusion of the indication of UVB phototherapy for the treatment of leukoderma by the AL7000 is supported in a clinical study which utilized a 308nm excimer laser to successfully induce repigmentation on subjects. These subjects had experienced hypopigmentation (leukoderma) as a result of carbon dioxide laser resurfacing, and confirmed a 50% to 75% improvement or greater in treating leukoderma.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K885026, K934808, K011197, K992914, K003705, K011382
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.
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510(k) SUMMARY PhotoMedex, Inc. XTRAC Excimer Laser System, Model AL7000
1. GENERAL
PhotoMedex, Inc. . Submitter: 2431 Impala Drive Carlsbad, CA 92008
- Contact Person: Bob Rose . March 13, 2002 Date Prepared: ●
2. DEVICE NAME
- Classification Name: Laser surgical instrument for use in general and plastic . surgery and in dermatology (21 CFR §878.4810)
- Common or Usual Name: XeCl excimer laser .
- Trade or Proprietary Name: XTRAC Excimer Laser System, model AL7000 .
3. PREDICATE DEVICES
Ultraviolet Phototherapy Systems
- HOUVA II, Phototherapy System, National Biological Corporation, -510(k) number: K885026
- UviSol, Phototherapy System, National Biological Corporation, --510(k) number: K934808 DermaClear UV-B Phototherapy System, Coherent Star/Lumenis 510(k) number K011197
- Excimer Laser
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20847 2/3
4. DEVICE DESCRIPTION
The XTRAC Excimer Laser System is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate an operator selected doseand 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 footswitch. The laser is enclosed in a protective interlocked housing.
5. INTENDED USE
The intended use is targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and non-autoimmune based leukoderma of affected skin.
6. SUBSTANTIAL EQUIVALENCE
The application of the XTRAC Excimer Laser System has been proven to be substantially equivalent to current legally marketed devices in the treatment of vitiligo via K003705. In that application, PhotoMedex demonstrated that narrow-band UV-B 311 alone had been shown to be just as effective in the treatment of vitiligo as PUVA (Westerhof and Nieuweboer-Krobotova). The authors in this study concluded, "the treatment of vitiligo with narrow-band UV-B twice weekly is a safe and effective treatment." Vitiligo, which is recognized as a cosmetic problem, is a form of leukoderma.
Current published data supports narrow-band UVB (utilizing ultraviolet lamp sources) to be effective in the regimentation of skin which has been affected by leukoderma such as the latent hypopigmentation, which is frequently experienced in complications resulting from carbon dioxide lasers used for skin resurfacing.
The intended use for the PhotoMedex XTRAC Excimer Laser System is within the scope of the predicate ultraviolet lamps. Both device types share the same methods and mechanisms (UVB light) to produce a result for the purpose of dermatological phototherapy.
The XTRAC Excimer Laser System, model AL7000 is currently market cleared for other skin conditions where UVB phototherapy has shown to be safe and effective via 510(k) numbers K992914, K003705, and K011382.
XVI-3
4 Westerhof W, Nieuweboer-Krobotova L. Treatment of vith UV-B radiation vs topical psoralen plus UV-A. Arch Dermatol 1997, 133:1525-1528.
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7. CLINICAL PERFORMANCE TESTING
Verification and validation to substantiate inclusion of the indication of UVB phototherapy for the treatment of leukoderma by the AL7000 is supported in a clinical study which utilized a 308nm excimer laser to successfully induce repigmentation on subjects. These subjects had experienced hypopigmentation (leukoderma) as a result of carbon dioxide laser resurfacing, and confirmed a 50% to 75% improvement or greater in treating leukoderma.
8. PRODUCT PERFORMANCE TESTING
Testing conducted on the XTRAC Excimer Laser System includes conformance to all relevant international EN 60601 series of standards, 21 CFR Part 1040.10 & 1040.11 Performance Standards for Light-Emitting Products and is a UL 2601 classified device.
9. CONCLUSIONS
Based on the same intended use as UVB sources for phototherapy, the previously cleared technological characteristics of the XTRAC Excimer Laser (which are unchanged to support this additional indication), and the performance data, PhotoMedex believes that the XTRAC Excimer Laser System is substantially equivalent to the predicate devices.
XVI-4
5 Friedman. Paul MD, Geronemous, Roy MD, Use of the 308-nm Excimer Laser for Postresurfacing Leukoderma, ARCH DERMATOL, vol. 137, June 2001, 824-825.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Bob Rose Director of Regulatory Affairs and Quality Assurance Photo Medex, Inc. 2431 Impala Drive Carlsbad, CA 92008
Re: K020847
R020017
Trade/Device Name: XTRAC Excimer Laser System, Model AL7000 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 13, 2002
Received: March 15, 2002
Dear Mr. Rose:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your because is substantially equivalent (for the indications referenced above and nave actering only marketed predicate devices marketed in interstate 101 as suated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the excordance 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 I ou may, mererere, mains of the Act include requirements for annual registration, listing of general volurold provider of of the startice, 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 exassinod (too as courols. Existing major regulations affecting your device can may be subject to back access 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 r 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 I 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 Of R rate 077) wouldy 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 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
forCelia 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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510(k) Number (if known): K020847
XTRAC Excimer Laser System, model AL7000 Device Name:
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 _
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number II-2 K02089