The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black tattoos and benign dermal and epidermal piqmented lesions, and, 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

Using a wavelength of 694 nm., the LaseAway Long Pulse and Q-Switched Ruby Laser System consists of a Long Pulse and Q-Switched ruby laser together with an articulated delivery arm and focusing optics. The laser parameters are managed by an analog control unit which is coupled to the main system and calibration is facilitated by an energy detector in the front panel. The pulse operation is initiated by a footswitch and a visible helium neon laser to provide guidance for accurate beam delivery.

AI/ML Overview

The provided text is a 510(k) summary for the Polytec PI, Inc. LaseAway Long Pulse and Q-Switched Ruby Laser System. It focuses on demonstrating substantial equivalence to predicate devices for the treatment of tattoos, pigmented lesions, and hair removal.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific percentage of tattoo clearance or hair reduction). Instead, it relies on demonstrating equivalence to predicate devices and the safety and effectiveness shown in a clinical study.

The primary "reported device performance" for clinical claims is the conclusion of substantial equivalence to predicate devices based on a clinical study for hirsutism. For non-clinical tests, the performance indicates compliance with safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
Clinical - Hirsutism Treatment: Substantial equivalence to legally marketed devices in safety and effectiveness for hair removal.	A clinical study was conducted, and the data was summarized to demonstrate the equivalence of the LaseAway system to legally marketed devices. The IRB considered the protocol a non-significant risk device.
Clinical - Tattoo/Pigmented Lesions: Substantial equivalence to predicate devices for removal of blue/black tattoos and benign dermal/epidermal pigmented lesions.	Demonstrated substantial equivalence in intended use, method of operations, material, and design (as compared to predicate devices for these indications) and supported by clinical data (though specific details are not provided for these indications explicitly beyond the hirsutism study).
Non-Clinical - Electrical Safety: Compliance with IEC-601-1.	Testing conducted per IEC-601-1 (electrical isolation). No violations found.
Non-Clinical - EMC Testing: Compliance with IEC 601-1-2.	Testing conducted per IEC 601-1-2 (EMC testing). No violations found.
Non-Clinical - General Safety/Effectiveness: Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" DCRND (Electrical, Mechanical and Environmental Performance Requirements).	Testing demonstrated no design characteristics that violated requirements or resulted in safety hazards.

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 for Test Set: The sample size for the clinical study is not provided in the document.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The study was conducted with "written consent from patients" and under an IRB protocol, indicating it was a prospective clinical study.

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)

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical study. It only mentions that the data was analyzed to demonstrate equivalence. For laser aesthetic devices, ground truth often involves photographic documentation and physician assessment of treatment outcomes.

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

The document does not specify any adjudication method used for the clinical study data.

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

This device (a laser system) is not an AI-powered diagnostic or assistive technology for human "readers," so an MRMC comparative effectiveness study would not be applicable in this context. The study performed was a clinical trial to assess the safety and effectiveness of the laser itself.

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

This question is not applicable as the device is a medical laser system, not an algorithm. Its performance inherently involves human operation and direct interaction with the patient.

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

For the clinical study related to hirsutism, the ground truth would typically be outcomes data, assessed through methods such as:

Physical examination by a clinician (e.g., hair count, visual assessment of reduction).
Patient self-assessment.
Standardized photography.

The document does not explicitly detail the specific metrics used for "outcomes data."

8. The sample size for the training set

This question is not applicable. This device is a physical laser system, not a machine learning algorithm that requires a "training set."

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

This question is not applicable for the same reason as above; there is no "training set" for a physical medical device like this laser system.

Summary

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K971193

JUN 2 4 1997

EXHIBIT 1 Page 1 of 4

510 (K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

971193 The assigned 510 (k) number is:

1. Submitter's Identification:

Polytec PI, Inc. 23 Midstate Drive, Suite 104 Auburn, MA 01501

Contact Person: Mr. Mark Boardman Manager - Medical Laser Products

Date Summary Prepared: March 28, 1997

2. Name of the Device:

LaseAway Long Pulse and Q-Switched Ruby Laser System

3. Predicate Device Information:

1. LaseAway Q-Switched Ruby Laser System, K#942343, Polytec PI, Inc.
Epilaser™ Normal Mode Ruby Laser, K#963947, Spectrum 2. Medical Technologies
EpiTouch™ Ruby Laser System, K#962996, Sharplan 3.

4 . Device Description:

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EXHIBIT 1 Page 2 of 4

5. Intended Use:

6. Comparison to Predicate Devices:

The LaseAway Long Pulse and Q-Switched Ruby Laser System is substantially equivalent in design and function to other ruby laser systems on the market, specifically:

1. The Polytec PI, Inc. LaseAway Q-Switched Ruby Laser System, K#942343;
1. The Spectrum Medical Technologies EpiLaser™ Normal Mode Ruby Laser, K#963947; and
The Sharplan EpiTouch™ Ruby Laser System, K#962446. 3.

The LaseAway Long Pulse and Q-Switched Ruby Laser System device is a Long Pulse and Q-Switched Ruby Laser and both the EpiLaser™ and EpiTouch devices are Non-Q-Switched (Long Pulse Exhibit #2 outlines all parameter differences; the Ruby) . intended use of the Sharplan Ruby Laser System is limited to use in dermatology for the removal of unwanted dark body hair.

A comparative description of the EpiTouch™ and EpiLaser™ devices to the LaseAway Long Pulse and Q-Switched Ruby Laser System is outlined below:

. The EpiLaser™ (Spectrum Medical Technologies):
The Epilaser™ is a non-Q-Switched, long pulse, flashlamp pumped ruby laser with a wavelength of 694 nanometers. EpiLaser has an energy output of 25 joules allowing it to have a maximum fluences at 9 mm of 40 joules/cm² with a repetition rate of 0.5 Hz. The EpiLaser™ has a peak power output of 8.3 kilowatts with a pulse duration of 3 milliseconds. The laser beam is delivered to the treatment site through an articulated arm and a focusing handpiece where patient contact is made

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EXHIBIT 1 Page 3 of 4

with a water cooled sapphire tip. The power supply needed for the system is 220 volts AC plus or minus 7 percent with a 30 amp current draw and an alternating current cycle 50 or 60 hertz. The exterior dimensions of the system are 40 inches tall by 24 inches wide by 44 inches deep and an operation weight of 790 pounds.

The major differences between the EpiLaser™ and LaseAway are the pulse width which is longer in the EpiLaser™ by almost 2 milliseconds, the energy delivery spot size which is almost double in the EpiLaser and the peak power which is higher in the Epilaser by almost 3 kilowatts. The minor differences are cooling handpiece, the exterior dimensions, in the the operating weight and the current draw needed to run the systems.

. The EpiTouch™ (Sharplan):
The EpiTouch™ is a Q-Switched, long pulse, flashlamp pumped ruby laser with a wavelength of 694 nanometers. EpiTouch has an energy output of 5 joules allowing it to have a maximum fluences at 4 mm of 40 joules/cm² with a repetition rate of The EpiLaser™ has a peak power output of 1.2 Hz. 5.5 kilowatts with a pulse duration of 0.9 milliseconds. The laser beam is delivered to the treatment site through an articulated arm and a focusing handpiece where patient contact is made with an anodized aluminum. The power supply needed for the system is 220 volts AC plus or minus 10 percent with a 10 amp current draw and an alternating current cycle 50 or 60 hertz. The exterior dimensions of the system are 45 inches tall by 29 inches wide by 33 inches deep and an operating weight of 440 pounds.

The only difference between the EpiTouch™ and the LaseAway Long Pulse and Q-Switched Ruby Laser System is the exterior The LaseAway Long Pulse and Q-Switched Ruby Laser size. System is 24 inches tall by 47 inches wide by 21 inches deep.

7 . Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the LaseAway Long Pulse and Q-Switched Ruby Laser System, in

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EXHIBIT 1 Page 4 of 4

the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements.

Testing was conducted on the LaseAway Long Pulse and 0-Switched Ruby Laser System device per IEC-601-1 (electrical isolation) and IEC 601-1-2 (EMC testing).

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.

8 . Discussion of Clinical Tests Performed:

A clinical study was conducted using the device to support the claim for the treatment of hirsutism. A description of the protocol, including patient population, the results of the study and a summary of the data and analysis of the data to demonstrate the equivalence of the LaseAway Long Pulse and Q-Switched Ruby Laser System to legally marketed devices was supplied to the FDA. The aforementioned clinical data was obtained under IRB with written consent from patients. Included is a statement from the IRB that our protocol contents were considered under a non-significant risk device. The clinical data was obtained in accordance with 21 CFR Parts 50 and 56.

9 . Conclusions:

The LaseAway Long Pulse and Q-Switched Ruby Laser System has the same intended use as the Spectrum Medical Technologies EpiLaser™ device and is similar in design and technology as this device as well as the Sharplan EpiTouch™ device: As our "Comparison to Predicate Devices" Section 6 outlines, as well as our clinical data, the LaseAway Long Pulse and Q-Switched Laser System raises no new questions of safety Ruby or effectiveness. Thus, when compared to the predicate devices, the LaseAway Long Pulse and Q-Switched Ruby Laser System did not incorporate any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan D. Goldstein-Falk Official Correspondent Polytec PI, Inc. . . . . . -23 Midstate Drive, Suite 212 Auburn, Massachusetts 01501

.UN 2 4 1997

Re: K971193

Trade Name: LaseAway Long Pulse and O-Switched Ruby Laser System Regulatory Class: II Product Code: GEX Dated: March 28, 1997 Received: April 1, 1997

Dear Ms. Goldstein-Falk:

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 commiance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Susan D. Goldstein-Falk

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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EXHIBIT #B

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Page 1 of 1

Device Name: LaseAway Long Pulse and Q-Switched Ruby Laser System

Indications For Usc:

The LaseAway Long Pulse and Q-Switched Ruby Laser System is
intended to remove blue/black tattoos-and basiness on the intended to remove blue/black tattoos-and benign dermil and epitermal pigmented lesions, and, "to effect land and of melanin in hair follicles in dermany select be targeting of melanin in hair follicles in dermatology and plastic surgery.

(PLEASE DO NOT WRITE BELOW THESS LINE - CONTINUE ON ANOTHER PAGE IF MEEDED)

Concernence of CDRH, Office of Device Evaluation (ODE)

Elin Wilk

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971193

Prescription Use_ (/ (Per 21 CFR 801.109)

Over-The-Counter Use

(Cptical Formal 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.