XTRAC ULTRA 2, MODEL AL10000

K073659 · Photo Medex, Inc. · GEX · Mar 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073659
• Device Name: XTRAC ULTRA 2, MODEL AL10000
• Applicant: Photo Medex, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 5, 2008
• 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 treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Device Story

XTRAC Ultra2 Excimer Laser System (Model AL10000) is a self-contained, compact UVB laser light source; utilizes XeCl gas mixture to generate monochromatic 308 nm ultraviolet light. System components include touch-screen display, fiberoptic cable with handpiece, and foot-switch for exposure initiation. Operated by clinicians in dermatological settings. Clinician selects dose; device delivers targeted, dose-controlled phototherapy to skin lesions. Increased repetition rate compared to predicates. Benefits include precise, localized treatment of skin conditions; minimizes exposure to healthy surrounding tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence based on identical indications for use and technological characteristics to previously cleared predicate devices. Bench testing performed to confirm conformance to IEC 60601 series, 21 CFR 1040.10 & 1040.11, UL 60601-1, and ISO 14971 risk management standards.

Technological Characteristics

XeCl excimer laser; 308 nm monochromatic UVB output. Components: touch-screen, fiberoptic cable, handpiece, foot-switch. Power: AC wall outlet (universal voltage). Standards: IEC 60601 series, UL 60601-1, 21 CFR 1040.10/1040.11. Risk management per ISO 14971.

Indications for Use

Indicated for targeted UVB phototherapy in patients with psoriasis, vitiligo, atopic dermatitis, and leukoderma.

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

• Excimer Laser Phototherapy System, model AL7000, AccuLase (K992914)
• XTRAC Excimer Laser System, Model AL 7000 (K003705)
• XTRAC Excimer Laser System, Model AL7000 (K011382)
• XTRAC Excimer Laser System, Model AL7000 (K020847)
• XTRAC XL Plus Excimer Laser System, Model AL7000 (K031451)
• XTRAC XL2 (XTRAC Ultra) Excimer Laser System, Model AL8000 (K041943)

Submission Summary (Full Text)

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PhotoMedex

MAR - 5 2008

510(k) Summary XTRAC Ultra2 Excimer Laser, Model AL10000

K673659

### 510(k) SUMMARY PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, Model AL10000

#### 1. GENERAL

- PhotoMedex, Inc. Submitter: . 2375 Camino Vida Roble, Suite B Carlsbad, CA 92011
- Jeff Levatter . Contact Person:
- December 21, 2007 Date Prepared: ●

#### 2. DEVICE NAME

- Laser surgical instrument for use in general and plastic . Classification name: surgery and in dermatology (21 CFR §878.4810)
- Common or usual name: XeCl excimer laser .
- Trade or proprietary name: XTRAC Ultra2 Excimer Laser System, Model AL10000 .

#### 3. PREDICATE DEVICES

#### Excimer Laser

- Excimer Laser Phototherapy System, model AL7000, AccuLase (PhotoMedex), . cleared via 510(k) K992914
- XTRAC Excimer Laser System. Model AL 7000, PhotoMedex, Inc., cleared via . 510(k) K003705
- XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via . 510(k) K011382
- XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via . 510(k) K020847
- XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. . cleared via 510(k) K031451
- XTRAC XL2 (now known as the XTRAC Ultra) Excimer Laser System, Model . AL8000, PhotoMedex, Inc. cleared via 510(k) K041943

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# PhotoMedexs

510(k) Summary XTRAC Ultra2 Excimer Laser, Model AL10000

#### 4. DEVICE DESCRIPTION

The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.

#### 5. INTENDED USE

The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

#### 6. SUBSTANTIAL EQUIVALENCE

The application of the Excimer Laser phototherapy has been proven to be substantially equivalent to current legally marketed devices in the treatment of indications previously cleared by CDRH (ODE). PhotoMedex has been granted clearance via K992914, K003705, K011382, K020847, K031451 and K041943 for this method of phototherapy generation.

The intended use for the PhotoMedex XTRAC Ultra2 Excimer Laser System, Model AL10000, and the identified predicate devices are identical in that they are all excimer lasers used to produce monochromatic (308nm) UVB light for the purpose of targeted, dose controlled UVB (dermatological) phototherapy. The difference between the XTRAC Ultra2 Excimer Laser System, Model AL10000, and the identified predicates is limited to a moderate increase in the maximum laser repetition rate. We believe the reprate increase will not affect the device's safety or intended use as compared to the identified predicates.

#### 7. CLINICAL PERFORMANCE TESTING

All clinical indications requested in this application have been previously cleared in the identified predicate devices. The XTRAC Ultra2 Excimer Laser System, Model AL10000 does not introduce any new indications for use, and will perform in an identical manner as the identified predicates, therefore PhotoMedex believes duplicative clinical data is not required as a condition of granting market clearance for the XTRAC Ultra-Excimer Laser System, Model AL10000.

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# PhotoMedexs

510(k) Summarv XTRAC Ultra2 Excimer Laser, Model AL10000

#### 8. PRODUCT PERFORMANCE TESTING

Testing and certification relevant to the XTRAC Ultra2 Excimer Laser System, Model AL10000 includes conformance to current applicable international IEC 60601 series of standards, 21 CFR Part 1040.10 & 1040.11, Performance Standards for Light-Emitting Products, and also includes certification to the UL 60601-1 Medical Electrical Equipment classification standard. Products are produced and distributed within a facility that has been registered with the FDA to manufacture medical devices. The XTRAC Ultra" Excimer Laser System, Model AL10000 also has been reviewed for risk management utilizing ISO 14971, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards.

#### 9. CONCLUSIONS

PhotoMedex believes the XTRAC Ultra2 Excimer Laser System, Model AL10000 is substantially equivalent to the identified predicates in that it does not introduce any new issues of safety or efficiency as compared to the predicates. The indications for use, methods of operation and power source are identical to the predicates.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PhotoMedex, Inc. % Mr. Jeff Levatter Chief Technology Officer 2375 Camino Vida Roble, Suite B Carlsbad, California 92011

MAR - 5 2008

Re: K073659

Trade/Device Name: XTRAC Ultra2 Excimer Laser System Model AL10000 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: December 21, 2007 Received: January 2, 2008

Dear Mr. Levatter:

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. Ilsting 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

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Page 2 - Mr. Jeff Levatter

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PhotoMec

510(k); Premarket Notification XTRAC Ultra2 Excimer Laser, Model AL10000

### Indications for Use

510(k) Number (if known): K (0736 5 9

XTRAC Ultra2 Excimer Laser System Model AL10000 Device Name:

Indications For Use:

UVB Phototherapy for 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)

of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative. and Neurological Devices II-2

510(k) Number_