The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for I no rulomar buper and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin. subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph suboutined about and glands, and glands, and specifically for the following indications.

Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

Device Description

The SLP™ 2000 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms, and a selectable pulse energy of .5-100 J. The corresponding fluence delivered through a 10 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 5 Hz by diodes located in the laser unit. The complete system consists of a laser unit, chiller, a footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.

AI/ML Overview

The provided text describes the Palomar SLP™ 2000 Diode Array Laser System and its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those acceptance criteria in the format requested.

The crucial sentence regarding performance is: "The differences in the specifications of the SLP™ 2000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy." This statement indicates that the device's performance is deemed equivalent to the predicate, but it does not provide quantitative acceptance criteria or a study with specific measurements against those criteria.

Therefore, many of the requested fields cannot be filled. I will fill in what information is available and indicate where information is not present.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in terms of quantitative measures)	Differences in specifications of SLP™ 2000 and predicate device do not result in different performance or raise new questions of safety or efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified. The document relies on substantial equivalence to a legally marketed predicate device (LightSheer Diode Array Laser, K973324) rather than presenting new performance data from a specific study of the SLP™ 2000 against explicit acceptance criteria.

3. 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 as no specific test set or ground truth establishment process is described for the SLP™ 2000.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no specific test set is described.

5. 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 MRMC comparative effectiveness study was done. This device is a laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable as no specific ground truth for performance evaluation of the SLP™ 2000 against quantitative acceptance criteria is described. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable as this is a laser system, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable as this is a laser system, not a machine learning model.

Summary

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Attachment V

K994225

510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the SLP™ 2000 Diode Array Laser System is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

Applicant:	Palomar Medical Technologies, Inc.
Address:	82 Cambridge St.Burlington, MA 01803
Contact Person:	Marcy Moore
Telephone:	919-363-2432
Preparation Date:	November 15, 1999
Device Trade Name:	Palomar SLP™ 2000
Common Name:	Super Long Pulse Diode Laser
Classification Name:	Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79
Legally-Marketed Predicate Device:	LightSheer Diode Array LaserStar Medical Technologies, Inc.K973324
System Description:	The SLP™ 2000 delivers infrared laser lightwith a wavelength of 810 nm, a selectable pulseduration of 50 - 1000 ms, and a selectable pulseenergy of .5-100 J. The corresponding fluencedelivered through a 10 mm handpiece tip. The laserpulses are generated at a maximum pulse repetitionfrequency of 5 Hz by diodes located in the laserunit

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	The complete system consists of a laser unit, chiller, a footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.
Intended Use of the Device:	The SLP™ 2000 Diode Laser System is indicated to remove hair in Dermatology and Plastic Surgery procedures. It is also intended for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions.
Performance Data:	The differences in the specifications of the SLP™ 2000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Conclusion:	Based on the foregoing, the SLP™ 2000 Diode Array Laser System is substantially equivalent to the legally-marketed claimed predicate device, i.e., the LightSheer™ for hair removal.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

MAY 1 8 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Gary, North Carolina 27511

Re: K994225

Trade Name: Palomar SLP™ 1000 Regulatory Class: II Product Code: GEX Dated: March 27, 2000 Received: March 29, 2000

Dear Ms. Moore:

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.

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Page 2 - Ms. Marcy Moore

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 vour 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 vours.

Purnell Page

& & 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

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INDICATIONS FOR USE STATEMENT

510(K) Number: K994225________________________________________________________________________________________________________________________________________________________

Palomar SLP™ 1000 Device Name:

Indications for Use:

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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I limal (Division Sign-Off) Division of General Restorative Devices K994228 510(k) Number .

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

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.