XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

K020847 · Photo Medex, Inc. · GEX · May 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020847
• Device Name: XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
• Applicant: Photo Medex, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and non-autoimmune based leukoderma of affected skin.

Device Story

XTRAC Excimer Laser System (Model AL7000) is a self-contained, compact UV laser light source. It utilizes a XeCl gas mixture to generate targeted 308 nm ultraviolet light. The system comprises a keypad/display, fiberoptic delivery system, handpiece, and footswitch, all housed in a protective interlocked enclosure. Operated by clinicians in a medical setting, the device delivers targeted phototherapy to affected skin areas. The clinician selects the dose and targets the specific lesion. The output is a 308 nm laser beam used to induce repigmentation in conditions like vitiligo and leukoderma, or to treat inflammatory skin conditions. By providing localized UV exposure, the device aims to achieve therapeutic outcomes while minimizing exposure to healthy surrounding skin.

Clinical Evidence

Clinical study evaluated the 308nm excimer laser for treating post-resurfacing leukoderma. Subjects showed 50% to 75% or greater improvement in repigmentation. Supporting literature (Westerhof and Nieuweboer-Krobotova) compared narrow-band UV-B to PUVA for vitiligo, concluding twice-weekly treatment is safe and effective.

Technological Characteristics

XeCl excimer laser; 308 nm wavelength; fiberoptic delivery system; keypad/display interface; footswitch control; protective interlocked housing. Conforms to EN 60601 series, 21 CFR 1040.10 & 1040.11, and UL 2601 standards.

Indications for Use

Indicated for patients with psoriasis, vitiligo, atopic dermatitis, and non-autoimmune based leukoderma requiring targeted UVB phototherapy.

Regulatory Classification

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.

Predicate Devices

• HOUVA II, Phototherapy System (K885026)
• UviSol, Phototherapy System (K934808)
• DermaClear UV-B Phototherapy System (K011197)
• XTRAC Excimer Laser System, model AL 7000 (K992914)
• XTRAC Excimer Laser System, model AL 7000 (K003705)
• XTRAC Excimer Laser System, model AL 7000 (K011382)

Submission Summary (Full Text)

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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
- XTRAC Excimer Laser System, model AL 7000, PhotoMedex, Inc., -510(k) numbers: K992914, K003705, and K011382

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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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