(150 days)
Not Found
No
The device description and performance studies focus solely on the laser technology and its application for phototherapy, with no mention of AI or ML.
Yes
The device is explicitly indicated for "UVB Phototherapy for Psoriasis" and a performance study confirms its "safety and effectiveness... for the treatment of Psoriasis," which is a therapeutic purpose.
No
The device is described as a phototherapy system that generates ultraviolet light for the treatment of Psoriasis, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly details hardware components such as a laser light source, keypad, display, fiberoptic delivery system, footswitch, handpiece, and protective housing.
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." This describes a therapeutic treatment applied directly to the patient's skin, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a laser system that delivers UV light. This is a physical therapy device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The device is clearly described as a phototherapy system used for treating a skin condition.
N/A
Intended Use / Indications for Use
UVB Phototherapy for Psoriasis
Product codes
GEX
Device Description
The Excimer Laser Phototherapy System, AL7000 is a complete self-contained compact laser light source, which utilizes a XeCl gas mixture to generate ultraviolet light at wavelength of 308 nm wavelength. The laser system consists of a keypad and display, a fiberoptic delivery system, a footswitch, and a handpiece. 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
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)
A dose response study using a 308 nm excimer laser showed the safety and effectiveness of the excimer laser for the treatment of Psoriasis.
Testing conducted on the Excimer Laser Phototherapy System, AL7000 includes conformance to all relevant International EN 60601 / IEC 601 series of standards and applicable laser standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
JAN 27 2000
:
K 992914
510(k) SUMMARY AccuLase, Inc. Excimer Laser Phototherapy System, AL7000
1. GENERAL
- . Submitter : AccuLase, Inc. 2431 Impala Drive Carlsbad, CA 92008
- Contact Person: Al Memmolo .
- Dute Prepared: January 14, 1999 .
2. DEVICE NAME
- . Classification nume: Ultraviolet lamp for dermatological disorders (ner 21 CFR 8878.4630)
- Common or usual name: XeCl excimer laser .
- . Trade or proprietary name: Excimer Laser Phototherapy System, AL7000
3. PREDICATE DEVICES
Ultraviolet Lamps
- HOUVA II, Phototherapy System . National Biological Corporation 510(k) number: K885026
- UviSol, Phototherapy System . National Biological Corporation, 510(k) number K934808
Excimer Laser
- CVX-300 Excimer Laser System . Spectranetics Corp. PMA number: P910001
1
510 (k) Summary AL 7000
4. DEVICE DESCRIPTION
The Excimer Laser Phototherapy System, AL7000 is a complete self-contained compact laser light source, which utilizes a XeCl gas mixture to generate ultraviolet light at wavelength of 308 nm wavelength. The laser system consists of a keypad and display, a fiberoptic delivery system, a footswitch, and a handpiece. The laser is enclosed in a protective interlocked housing.
5. INTENDED USE
UVB phototherapy for Psoriasis
6. SUBSTANTIAL EQUIVALENCE
The intended use for the AccuLase Excimer Laser Phototherapy System, AL.7000 is identical to that of the predicate ultraviolet lamps. Both device types share the same methods and mechanisms of treatment.
The Excimer Laser Phototherapy System is substantially equivalent to the technological characteristics of the predicate excimer laser device. Both devices share the same operating principles and produce un identical wavelength.
7. CI.INICAL PERFORMANCE DATA
A dose response study using a 308 nm excimer laser showed the safety and effectiveness of the excimer laser for the treatment of Psoriasis.
8. PRODUCT PERFORMANCE TESTING
Testing conducted on the Excimer Laser Phototherapy System, AL7000 includes conformance to all relevant International EN 60601 / IEC 601 series of standards and applicable laser standards.
9. CONCLUSIONS
Based on the same intended use as ultraviolet lamps, the similar technological characteristics of the excimer lasers, and the clinical and performance data, AccuLase believes that the Excimer Laser Phototherapy System, AL7000 is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 2000
Mr. Al Memmolo Director, Quality Assurance and Regulatory Affairs AccuLase, Inc. 2431 Impala Drive Carlsbad, California 92008
Re: K992914
Trade Name: Excimer Laser Phototherapy System, AL 7000 Regulatory Class: II Product Code: GEX Dated: November 24, 1999 Received: November 29, 1999
Dear Mr. Memmolo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 - Mr. Al Memmolo
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
poella
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AccuLase, Inc. ( a subsidiary of Laser Photonics, Inc.)
K992914
510(k) Number (if known):
Device Name:
Excimer Laser Phototherapy, AL 7000
Indications For Use:
UVB Phototherapy for Psoriasis
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992914 |
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |