(288 days)
Not Found
No
The document describes a laser device for treating psoriasis and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is indicated for the treatment of psoriasis, which is a therapeutic use.
No
The device is described as being indicated for "treatment of psoriasis" and is a "medical device that is capable of emitting a treatment laser beam." There is no mention of it being used for diagnosis or detection.
No
The device description explicitly states it is a "medical device that is capable of emitting a treatment laser beam," indicating it is a hardware device (a laser) and not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of psoriasis." This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is described as a "medical device that is capable of emitting a treatment laser beam." This further reinforces its therapeutic nature.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, the SurgiLight EX-308 Excimer Laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. SurgiLight, Inc. seeks no new indications for the EX-308 Excimer Laser.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Phototherapeutix, Inc. 2480AB (K935525), National Biological Corporation Houva II (K885029)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K493328
510(k) Summary of Safety and Effectiveness The SurgiLight, Inc. EX-308
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety In response to the Sale Medical Devices Ale externing equivalence determination is based.
The safety and effectiveness of the SurgiLight, Inc. EX-308 is based upon a determination of the The sately and enectiveness of the safety and effectiveness of its predicate devices which substantial equivalence as wen as the satery and cercant the National Biological Corporation Houva II
- SurgiLight, Inc. Company: I. 12001 Science Drive Orlando, Florida 32826 J. T Lin, Ph.D.
- SurgiLight, Inc. EX-308 Excimer Laser Model: (1.
Predicate III. The Phototherapeutix, Inc. 2480AB (K935525) and the National Devices: Biological Corporation Houva II (K885029).
- The SurgiLight EX-308 Excimer Laser is a medical device that is capable Description: IV. of emitting a treatment laser beam at a wavelength of 308nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
- V. Indications The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related For Use: accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. SurgiLight, Inc. seeks no new indications for the EX-308 Excimer Laser. No new indications were sought in this premarket notification, clinical data was presented.
48
1
- From a design and clinical perspective, the predicate and candidate laser devices, Summary: are of similar technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Surgil ight, Inc. believes that no significant differences exist. Therefore, the SurgiLight, Inc. EX-308 should not raise any concerns regarding its overall safety and/or effectiveness.
This information was prepared for the sole purpose of Advisory: compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight, representing health, hope, and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2000
Mr. Timothy J. Shea Executive Vice President and Chief Operating Officer SurgiLight, Inc. 12001 Science Drive, Suite 140 Orlando, Florida 32826
Re: K993328
Trade Name: EX-308 Excimer Laser Regulatory Class: II Product Code: GEX Dated: May 9, 2000 Received: May 9, 2000
Dear Mr. Shea:
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 (QS) 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.
3
Page 2 - Mr. Timothy J. Shea
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 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,
Omne R. Vochner.
Celia 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
4
Indications for Use
Page of
510(k) Number (If known): K993328
Device Name: SurgiLight, Inc. EX-308 Excimer Laser
Indications for Use:
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. Surgil.jght, Inc. seeks no new indications for the EX-308 Excimer Laser.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE TH NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Dome (Division Sign-Off) Division of General Restorative Devices 510(k) Number K99332
Prescription Use
1
Qr
Over-The-Counter Use
(Optional Format 1-2-96)