PALOMAR SLP 1000 by PALOMAR MEDICAL PRODUCTS, INC.

The SLP™ 1000 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 complete system consists of a power 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 power unit, which provides an interface to the system computer.

AI/ML Overview

The provided text does NOT describe acceptance criteria or a study that proves the device meets specific criteria.

Instead, the document is a 510(k) Summary of Safety and Effectiveness submission to the FDA for the Palomar SLP™ 1000 Diode Array Laser System. Its primary purpose is to demonstrate substantial equivalence to existing legally marketed predicate devices, not to prove performance against specific acceptance criteria for a new clinical indication.

Here's a breakdown of why the requested information cannot be extracted from this document:

No Acceptance Criteria or Performance Data: The document explicitly states: "The differences in the specifications of the SLPTM Performance Data: 1000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy." This means the submission is not presenting new performance data or acceptance criteria that would typically be associated with a clinical study to demonstrate efficacy. It's relying on the presumed safety and effectiveness of the predicate devices.
Focus on Substantial Equivalence: The conclusion clearly states, "Based on the foregoing, the SLP™ 1000 Diode Conclusion: Laser System is substantially equivalent to the legally-marketed claimed predicate device for permanent hair reduction." The FDA's letter also confirms this substantial equivalence determination. This is the core of a 510(k) submission.
Lack of Study Details: Because the submission relies on substantial equivalence and does not report new performance data, it naturally won't contain information about:
- Sample sizes (test or training sets)
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC studies or effect sizes
- Standalone algorithm performance
- Types of ground truth
- How ground truth was established

In summary, the provided text does not contain the information requested about acceptance criteria and a study to prove the device meets them because the submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against specific criteria through a new study.

Summary

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DEC 0 6 2001

Attachment 4

510(K) Summary of Safety and Effectiveness

人口13028

This 510(K) Summary of Safety and Effectiveness for the SLP™ 1000 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:	September 4, 2001
Device Trade Name:	Palomar SLP™ 1000
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 LaserLaserscope Lyra G Surgical Laser System
System Description:	The SLP™ 1000 delivers infrared laser light with awavelength of 810 nm, a selectable pulse durationof 50 - 1000 ms, and a selectable pulse energy of.5-100 J.The complete system consists of a power unit,chiller, a footswitch, and a handpiece connected tothe laser unit with an umbilical. In standard use, thehandpiece is pressed against the patient's skin and alight pulse is delivered when the footswitch isdepressed. The handpiece tip is water-cooled to

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provide active skin cooling. Laser parameters and other system features are controlled from the user interface panel on top of the power unit, which provides an interface to the system computer.

The SLP™ 1000 Diode Laser System is indicated Intended Use of the Device: for the treatment of pseudofolliculitis barbae, as well as hair removal, permanent hair reduction, treatment of pigmented and vascular lesions (including facial and leg veins).

The differences in the specifications of the SLPTM Performance Data: 1000 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy.

Based on the foregoing, the SLP™ 1000 Diode Conclusion: Laser System is substantially equivalent to the legally-marketed claimed predicate device for permanent hair reduction.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Palomar Medical Products, Inc. c/o Ms. Marcy Moore 131 Kelekent Lane Cary, North Carolina 27511

Re: K013028

Trade Name: Palomar SLP™ 1000 Diode Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 6, 2001 Received: September 10, 2001

Dear Ms. Moore:

We have reviewed your Section 510(k) premarket 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) 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 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.

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Page 2 & Ms. Marcy Moore

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to organization of substantial equivalence of your device to a legally premits that 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 II you desire specific advice for your witto diagnostic devices), please contact the Office of additionally 21 OF IC For of 559. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + 100 + Office of Compliance at (301) 594-4639. Also, please note the your deviced, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I guiation chittion, "Nilocraning on yesponsibilities under the Act may be obtained from the Outcr general informational 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,

Susan Walker, MD

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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: K013028

Palomar SLP™ 1000 Device Name:

Indications for Use:

The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for the treatment of pseudofolliculitis barbae in Skin Types I-VI.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √

Over-the-Counter Use_ OR (per 21 CFR 801.109)

Susan Walker, MD

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number Ka3028

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.