(99 days)
Given the input, there are no predicate devices listed. Therefore, the answer should be empty.
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML-powered devices. The description focuses solely on the intended use of an excimer laser for treating specific skin conditions.
Yes
The device is indicated for treating medical conditions (Psoriasis, vitiligo, atopic dermatitis, and leukoderma), which is a characteristic of a therapeutic device.
No
Explanation: The device is indicated for treating skin conditions, not for diagnosing them.
No
The device description is not found, but the intended use clearly describes a "Fencer 308 Excimer Laser," which is a hardware device used for medical treatment. This indicates it is not a software-only medical device.
Based on the provided information, the Fencer 308 Excimer Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating skin conditions (Psoriasis, vitiligo, atopic dermatitis, and leukoderma). This involves applying energy directly to the patient's body for therapeutic purposes.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The provided information does not mention any testing of samples from the body, analysis of biological markers, or diagnostic purposes based on laboratory analysis.
Therefore, the Fencer 308 Excimer Laser, as described, is a therapeutic device used for treating skin conditions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fencer 308 Excimer Laser will be indicated for use the Psoriasis, vitiligo, atopic dermatitis and leukoderma.
Product codes
GEX
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kera Harvest/Laser Max Medical Technologies Corporation % Paul Y. Fang, M.D., Ph.D. 1601 North Clancy Street Visalia, California 93291-9263
JUL 1 5 2008
Re: K080975
Trade/Device Name: Fencer 308 Excimer Laser 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: June 10, 2008 Received: June 13, 2008
Dear Dr. Fang:
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
1
Page 2 - Paul Y. Fang, M.D., Ph.D.
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 vour 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 080975
| Device Name: | Fencer 308 Excimer Laser |
|---|---|
| Indications For Use: | The Fencer 308 Excimer Laser will be indicated for use the Psoriasis, vitiligo, atopic dermatitis and leukoderma. |
Prescription use _ X (Part21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pepf
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number /978
510(k) Number K080975
and Neurological Devices
Division of General, Restorative,
(Division Sign-Off)