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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the SurgiLight, Inc. EX-308 Excimer Laser:

Important Note: The provided document is a 510(k) summary and FDA clearance letter, not a detailed study report. As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself. Therefore, many of the requested sections below will indicate that the information is "Not Delineated in the Provided Text" or point to the reliance on predicate device data.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics for the EX-308 itself. Instead, the acceptance is based on its substantial equivalence to predicate devices. The "reported device performance" for the EX-308 is implicitly that it performs equally to its predicates for the indicated use.

Acceptance Criterion	Reported Device Performance (SurgiLight EX-308)	Notes
Similar Technology	"are of similar technology"	Implies that the core laser mechanism and function are comparable to predicates.
Same Intended Use	"have the same intended use"	Explicitly for the "treatment of psoriasis," matching predicate devices.
No Significant Differences	"no significant differences exist"	This is the overarching "performance" criterion for equivalence. The device is deemed to perform as safely and effectively as predicates.
Safety and Effectiveness	"should not raise any concerns regarding its overall safety and/or effectiveness."	Conclusion drawn from the similarity to predicate devices.
Wavelength	308nm	Matches the wavelength typically used in excimer lasers for psoriasis, consistent with predicate technologies.
Pulsed Mode Capability	Capable of emitting in a pulsed mode at various repetition rates.	Standard feature for excimer lasers and implied to be comparable to predicates.

Study Details (or lack thereof, based on provided text)

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Delineated in the Provided Text. The document explicitly states: "No new indications were sought in this premarket notification, clinical data was presented." This indicates that a specific clinical study with a test set for the EX-308 was not conducted or submitted for this 510(k) clearance. The clearance is based on substantial equivalence to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable / Not Delineated in the Provided Text. Since no specific clinical data or test set for the EX-308 was presented, there was no ground truth establishment through expert consensus for this device's performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Delineated in the Provided Text. No specific test set was used for the EX-308's performance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a laser for medical treatment, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device (excimer laser) intended for therapeutic use, not a standalone software algorithm. Its operation involves a human operator (clinician).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicitly, the ground truth is established by the long-standing clinical use and safety/effectiveness of its predicate devices. For the EX-308 itself, no new ground truth was established as its clearance is based on equivalence. The predicate devices would have undergone their own studies and established their ground truth through clinical outcomes data for psoriasis treatment.
The sample size for the training set:
- Not Applicable / Not Delineated in the Provided Text. This is a hardware medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. As above, this device does not utilize a "training set" in the context of machine learning.

Summary

{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.

{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

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.