(3 days)
No
The summary describes a laser device with standard operational parameters (wavelength, pulse mode, repetition rates) and does not mention any AI/ML components, image processing, or data-driven decision-making.
Yes.
The device is indicated for the "treatment of psoriasis and for the treatment of vitiligo," which are therapeutic applications.
No
Explanation: The device is indicated for treatment of psoriasis and vitiligo, and emits a treatment laser beam. It is not described as diagnosing any condition.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of psoriasis and vitiligo. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is a laser that emits a treatment beam. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core function of IVDs.
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 is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
Product codes
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
The PhotoMedix K003705
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
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 and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Surgil.ight, Inc. EX-308 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the following: PhotoMedix
- SurgiLight, Inc. 1. Company: 12001 Science Drive Orlando, Florida 32826 J. T Lin, Ph.D.
- SurgiLight, Inc. EX-308 Excimer Laser II. Model:
- Predicate III. The PhotoMedix K003705 Devices:
- 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 quidance 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 is currently cleared for the treatment of psoriasis and will be indicated for use for the treatment of vitiligo. 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.
- 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, SurgiLight, 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2002
J. T. Lin, Ph.D. Director of Business and New Technology Development SurgiLight, Inc. 12001 Science Drive, Ste. 140 Orlando. FL 32826
Re: K020973
Trade/Device Name: SurgiLight, Inc. EX-308 Excimer Laser 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 27, 2001 Received: March 26, 2002
Dear Dr. Lin:
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 re rate rise wior 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 11 your de 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 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.
2
Page 2 - J. T. Lin, Ph.D.
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 (301) 594-4659. 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Miriam C. Provost
Salie M. Witte, Ph.D., M.D.
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
3
Indications for Use
Page (){
510(k) Number (If known): KO20923
Device Name: SurgiLight, Inc. EX-308 Excimer Laser
Indications for Use:
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020973
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
()r
Over-The-Counter Use
(Optional Format 1-2-96)