The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

Device Description

The upgrade kit for the Epilaser® I consists of a laser head with a slightly higher energy output, a fiber optic beam connector with a standard SMA 905 connector, a fiber optic, and modified hand pieces adapted with a quick connect to the fiber optic.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes an upgrade kit for an existing device, the Epilaser I Normal Mode Ruby Laser. The core of the submission is to demonstrate that the upgrade kit does not negatively impact the safety and effectiveness of the original device, and therefore, no new performance data is required.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
None stipulated for the upgrade kit. The document explicitly states: "Performance Data: None required."	The original Epilaser® I's operational specifications, performance, and intended use are not affected by the installation of the upgrade kit. The changes (e.g., fiber optic instead of articulated arm) do not affect performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set involving human subjects or performance data was required for this submission. The submission is based on the premise that the upgrade does not alter the device's performance.
Data Provenance: Not applicable, as no new performance data was generated or analyzed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment related to a test set was required as no new performance data was generated for the upgrade kit.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was performed.

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

Not applicable. This device is a laser for hair removal, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

Not applicable. This is a medical device (laser), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No new ground truth was established for the upgrade kit. The regulatory decision hinges on the substantial equivalence to the predicate device, which inherently relied on the predicate possessing established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (laser), not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this case is not a traditional clinical or performance study with new data generation. Instead, the "proof" is a regulatory argument of substantial equivalence to a legally marketed predicate device (the Epilaser I before the upgrade).

The acceptance criteria are effectively that the upgraded device maintains the safety and effectiveness of the predicate device. The study to prove this involved:

Comparison of Technical Specifications: The submission details that the upgrade kit consists of a laser head with slightly higher energy output, a fiber optic beam connector, a fiber optic, and modified hand pieces.
Assessment of Impact on Operational Specifications, Performance, and Intended Use: The core argument is stated as: "The operational specifications, performance and intended use of the Epilaser® I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser® I."
Conclusion of Substantial Equivalence: Based on the above, the manufacturer concludes that the Epilaser I with the upgrade kit is substantially equivalent to the Epilaser I without the upgrade kit.

Therefore, the "study" is a technical and regulatory justification rather than a data-driven performance study. The FDA's letter (K980160) confirms their agreement with this assessment, stating, "We have determined the device is substantially equivalent... You may, therefore, market the device..." and that "The FDA finding of substantial equivalence... results in a classification for your device and thus, permits your device to proceed to the market." The underlying performance data for the original Epilaser I (K963947) served as the basis for its initial market clearance, and this submission leverages that existing clearance by demonstrating that the upgrade causes no adverse change.

Summary

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MAR 1 0 1998

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K980160

APPENDIX E

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY

Epilaser® I Normal Mode Ruby Laser

This 510(k) summary of safety and effectiveness involves a post-sale upgrade of the Epilaser I and is submitted in accordance with the requirements of SMDA 1990 following Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	Palomar Medical Technologies, Inc.
Address:	45 Hartwell AvenueLexington, MA 02173
Contact Person:	Mr. Anthony FiorilloPresident, Palomar MedicalTechnologies, Inc.
Telephone:	617-676-7300617-676-7330 (Fax)
Preparation Date:(of the Summary)	December 1997
Device Trade Name:	Upgrade for the Epilaser® I (an accessory to the Epilaser® I).
Common Name:	Ruby Laser
ClassificationName	Laser surgical instrument; for use in general and plasticsurgery and in dermatology (see: 21 CFR 878.4810).Product Code: GEXPanel: 79
Legally marketedpredicate devices	The Epilaser® I is the legally marketed device. Installation of
Description ofthe Device:	The upgrade kit for the Epilaser® I consists of a laser head witha slightly higher energy output, a fiber optic beam connectorwith a standard SMA 905 connector, a fiber optic, andmodified hand pieces adapted with a quick connect to the fiberoptic.

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Intended Use of the Device:	The intended use Epilaser R I is not affected by installation of the upgrade kit.
Comparison:	The operational specifications, performance and intended use of the Epilaser R I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser R I.
Performance Data:	None required.
SUMMARY:	Installation of the upgrade kit has no effect on the performance, instructions for use, or indications of use for the Epilaser R I. The EpilaserR I performance and characteristics are not affected by the installation of the upgrade kit.
CONCLUSION:	The Epilaser R I laser after installation of the kit is substantially equivalent to the Epilaser R I prior to installation of the kit.
Additional Information	None requested

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines or strokes, which is the department's emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Mr. Anthony Fiorillo · President Palomar Medical Technologies, Incorporated 45 Hartwell Avenue Lexington, Massachusetts 02173

Re: K980160 Trade Name: Epilaser I Upgrade Kit Regulatory Class: II Product Code: GEX Dated: January 13, 1998 Received: January 16, 1998

Dear Mr. Fiorillo:

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. ਬੋ 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.

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Page 2 - Mr. Fiorillo

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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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980160

APPENDIX D

NOTE: The following indications for use are quoted from the Indications for Use statement for the Epilaser as described in K963947 (the laser has been renamed the Epilasers I). The indications for use in this APPENDIX are provided for the record; the installation of : ・ the upgrade kit does not affect or alter these indications. The upgrade kit itself does not have indications for use.
510(k) Number: 长安

Epilaser I Normal Mode Ruby Laser Device Name:

Indications for Use:

The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The Epilaser I was limited to prescription use at the substantially equivalent decision. (March 5, 1997). મે જ

(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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Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter-Use
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(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K980160
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007

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.