PALOMAR LUX1064 HANDPIECE by PALOMAR MEDICAL TECHNOLOGIES, INC.

The removal of unwanted hair for skin types I-VI, and to effect . stable long-term permanent hair reduction.
The treatment of benign pigmented lesions such as, but not t limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, caféau-lait macules, and plaques.
. Verrucae, skin tags, seborrheic keratosis,
Tattoos (significant reduction in the intensity of black and/or 속 blue-black tattoos).
The Lux1064™ is indicated for pigmented lessons to reduce . lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
The treatment of vascular lesions such as but not limited to, . port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
The Lux10641M is also indicated for the reduction of red ◆ pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Coagulation and hemostasis of soft tissue. ●
♥ Treatment of wrinkles.
Pseudofolliculitis barbae (PFB) ●

Device Description

The Lux1064™ is a versatile, light-based medicaldevice consisting of a base unit and handpieceattachments.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description with reported device performance against those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the Palomar Lux1064™ Nd:YAG Handpiece.

Here's what can be extracted and what is missing based on your request:

Missing Information:

The document explicitly states: "The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This strongly suggests that a new clinical study with specific acceptance criteria and performance metrics was not conducted for this 510(k) submission. Instead, the submission relies on the substantial equivalence principle, comparing the device to legally marketed predicate devices.

Therefore, the following information cannot be provided from the given text:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined for this device in the context of a new study.
Sample size used for the test set and the data provenance: No new test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
Adjudication method for the test set: Not applicable.
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: Not applicable, as this is not an AI/imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

What is available from the text:

The document confirms that this is a substantial equivalence (510(k)) submission, which means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical data to prove efficacy.

Conclusion on Performance (from the document):
"The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy."
"Based on the foregoing, the Lux1064™ System is substantially equivalent to the legally-marketed claimed predicate devices, i.e., the Lumenis IPL/NdYAG, Candela GentleYAG, and Laserscope Lyra series."

This statement is the key "proof" of the device meeting "acceptance criteria" in the context of a 510(k) submission, where the "acceptance criteria" is essentially demonstrating substantial equivalence to a predicate device already accepted for the market.

In summary, a detailed study with specific acceptance criteria and performance data for the Palomar Lux1064™ Nd:YAG Handpiece is not provided within this 510(k) submission. Its clearance is based on demonstrating substantial equivalence to existing, legally marketed devices for the stated indications for use.

Summary

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K041879 1/2

JAN 13 2005

Attachment 4

510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the Palomar StarLux™ Pulsed Light This JTV(K) Sullimary of Safety and Enterty, and Enternets of Safe Medical Device Act
System is submitted in accordance with the requirements of Safe Medical Device Act System is submitted in accordance with the requestion (ODE) guidance concerning the organization and content of a 510(K) summary.

Applicant:	Palomar Medical Technologies, Inc.
Address:	82 Cambridge St.Burlington, MA 01803781-993-2300
Contact Person:	Marcy Moore
Telephone:	919-363-2432
Preparation Date:	July 8, 2004
Device Trade Name:	Palomar Lux1064™ NdYAG Handpiece
Common Name:	Lux1064™
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:	StarLux™ Pulsed Light System (handpieces)Lumenis Family of IPL & IPL/NdYAG, CandelaGentle YAG, Laserscope LIRA
System Description:	The Lux1064™ is a versatile, light-based medicaldevice consisting of a base unit and handpieceattachments.
Intended Use of the Device:	The Lux1064™ is a light-based medical devicedesigned for effective removal of unwanted hair,permanent hair reduction, PFB, treatment of wrinklesand the treatment of vascular and pigmented lesions.

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K041879 2/2

Performance Data:

Conclusion:

The differences in the specifications of the Lux1064™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy.

Based on the foregoing, the Lux1064™ System is substantially equivalent to the legally-marketed claimed predicate devices, i.e., the Lumenis IPL/NdYAG, Candela GentleYAG, and Laserscope Lyra series.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2005

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

Re: K041879

Trade/Device Name: Palomar Lux1064™ Nd: YAG Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 22, 2004 Received: October 25, 2004

Dear Ms. Moore:

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 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) rms leter 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Muriam C. Provost

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:

Device Name: Palomar Lux 1064TM Nd: Y AG Handpiece

Indications for Use:

The Lux1064TM handpiece is indicated for:

The removal of unwanted hair for skin types I-VI, and to effect . stable long-term permanent hair reduction.
The treatment of benign pigmented lesions such as, but not t limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, caféau-lait macules, and plaques.
. Verrucae, skin tags, seborrheic keratosis,
Tattoos (significant reduction in the intensity of black and/or 속 blue-black tattoos).
The Lux1064™ is indicated for pigmented lessons to reduce . lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments.
The treatment of vascular lesions such as but not limited to, . port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
The Lux10641M is also indicated for the reduction of red ◆ pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Coagulation and hemostasis of soft tissue. ●
♥ Treatment of wrinkles.
Pseudofolliculitis barbae (PFB) ●

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam' ( Provost

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

510(k) Number_4/4/877

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.