The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face.
The 755 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for I-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.

Device Description

The MultiWave XR combines three laser outputs in a single device. It produces a long pulse laser light of 532 nm, 755 nm, and 1064 nm wavelengths. The laser head has two optical cavities containing an Alexandrite crystal rod (755 nm) and a Nd:YAG crystal rod (1064 nm) with optional frequency doubler installed (532 nm). Pulsed laser energy accomplished with a red aiming beam of low energy (5mW, 635nm) is delivered to a target via an optical fiber and a handpiece. Each laser outlet has own fiber and handpiece. Chilled air is delivered to the same target via jets in a handpiece.

AI/ML Overview

This 510(k) submission for the MultiWave XR laser system does not contain the detailed, quantitative acceptance criteria and study data typically found in clinical validation reports for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) cannot be directly addressed from the provided text.

Here's an attempt to extract and describe what is available, noting where information is absent:

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

This document does not present explicit "acceptance criteria" in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding quantitative results for the MultiWave XR itself. The "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices for the specified indications for use.

The "reported device performance" is essentially that it achieves similar therapeutic effects (permanent hair removal, treatment of vascular lesions, pigmented lesions, and wrinkles) as the predicate devices, as it shares identical technological characteristics and intended uses.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Implied by Equivalence)
Technological Equivalence: Flash lamp pumped Nd:YAG laser rod (1064 nm), Alexandrite laser rod (755 nm), optional frequency doubler (532 nm), optical fiber delivery system, aiming pilot lasers, microprocessor controlled, closed water-air cooling system.	MultiWave XR possesses these identical technological characteristics.
Intended Use Equivalence: Permanent hair removal, treatment of vascular lesions, pigmented lesions, and wrinkles. (Specific wavelengths for specific uses detailed in Indications for Use).	MultiWave XR is indicated for these same uses for its respective wavelengths.
Safety and Effectiveness: Does not raise new questions of safety and effectiveness compared to predicates.	The risk and benefits of the MultiWave XR laser system are comparable to the predicate devices when used for similar applications. No new questions of Safety and Effectiveness are raised.

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

Not applicable. This 510(k) relies on substantial equivalence to existing predicate devices, not on a new clinical study with a test set of patient data from a specific provenance. The "test set" in this context refers to the comparison of the device's design and intended use against those of the predicate devices.

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. Ground truth, in the context of clinical studies for AI/ML, isn't established here. The "ground truth" for this submission would be the FDA's prior clearance of the predicate devices, and the established safety and effectiveness of those technologies as understood by general medical consensus.

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

Not applicable. There is no clinical adjudication of patient cases described in this 510(k) submission.

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 system, not an AI/ML-driven diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Not applicable. This is a medical device (laser system), not a standalone algorithm.

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

Not applicable for a new clinical study. The "ground truth" is the established safety and effectiveness of the predicate devices based on their prior FDA clearances and established clinical use.

8. The sample size for the training set

Not applicable. This pertains to AI/ML models, not a physical laser device.

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

Not applicable. This pertains to AI/ML models, not a physical laser device.

Summary

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APPENDIXES

phone 1-(805)-640-8080 fax 1-(805)-640-8081

SEP - 9 2005

10.1.

K051876

Appendix A (510(k) Summary)

510(k) Summary

In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, the following is a summary of the safety and effectiveness information on which the substantial equivalence determination is based. The safety and effectiveness of the MultiWave XR laser system derives from a determination of substantial equivalence to the predicated devices listed below.

Pacific Quantum Instruments, Inc. Applicant 408 Bryant Circle, Suite F-1, Ojai, CA 93023 Address Gennady L. Nikolaenko, Ph.D., President & CEO Contact Person (805)-640-8080 Telephone (805)-640-8081 Fax nikolaenko@mailnew.com E-mail MultiWave XR Device Trade Name Medical Laser System Common Name Laser surgical instrument for use in general and plastic surgery and Classification Name dermatology (21 CFR 878.4810), Class II Product Code: GEX -- Laser, instrument, surgical, powered Panel: 79 1). GentleYAG (Candela), K022951, K023193 Predicate Devices 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030 6). Adept 1064/532/755 Laser (Adept Medical Concepts) K032218 The MultiWave XR combines three laser outputs in a single device. Device Description It produces a long pulse laser light of 532 nm, 755 nm, and 1064 nm wavelengths. The laser head has two optical cavities containing an Alexandrite crystal rod (755 nm) and a Nd:YAG crystal rod (1064 nm) with optional frequency doubler installed (532 nm). Pulsed laser energy accomplished with a red aiming beam of low energy (5mW, 635nm) is delivered to a target via an optical fiber and a handpiece. Each laser outlet has own fiber and handpiece. Chilled air is delivered to the same target via jets in a handpiece. The MultiWave XR laser system is indicated for permanent hair Intended Use removal, for treatment of vascular lesions, pigmented lesions, and wrinkles

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Appendix B (Summary of Substantial Equivalence) 10.2.

Summary of Substantial Equivalence

Pacific Quantum Instrument, Inc. believes that its MultiWave XR laser system is substantially equivalent:

a) regarding all three available in MultiWave XR laser emissions together (1064 nm, 755 nm and 532 nm), to the legally marketed device: Adept 1064/532/755 Laser (Adept Medical Concepts, Inc., K032218);
b) regarding 1064 nm laser emission, to the following legally marketed devices: 10Eaut 1064/532/755 Laser (K032218), GentleYAG (Candela, K022951), Gemini (Laserscope, K034011), Apogee Elite (Cynosure, K034030);
c) regarding 755 nm laser emission, to the following legally marketed devices: regarding 195 ml/7 asser (K032218), GentleLASE GL (Candela, K994260), Apogee Elite (Cynosure, K034030);
d) regarding 532 nm laser emission, to the following legally marketed devices: Adent 1064/532/755 Laser (K032218), Gemini (Laserscope, K034011), Aura i (Laserscope, K024206).

All these predicate devices previously cleared for medical applications, which include all Indications for Use of MultiWave XR proposed by Pacific Quantum Instruments, Inc. in the Indications for Use Statement (see Appendix 10.3)

Technologically, the predicate devices have identical characteristics to the MultiWave XR I connotegrounly, all comprising a flash lamp pumped Nd:Y AG laser rod generating light at 1064 iaser System, an onsperised Alexandrite laser rod generating light at 755 nm, which is subsequently delivered to the patient via individual optical fiber delivery system and focusing handpiece.

Moreover, all lasers are microprocessor controlled devices with internal closed water-air laser cooling system, and Class I, 635 nm, aiming pilot lasers, which pose no hazard to the user.

The risk and benefits of the MultiWave XR laser system are comparable to the predicate devices when used for similar applications. It is therefore believed that there are no NEW questions of Safety and Effectiveness raised by the introduction of this device: MultiWave XR laser system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gennady L. Nikolaenko, Ph.D. President and CEO Pacific Quantum Instruments, Inc. 408 Brvant Circle, Suite F-1 Ojai, California 93023

Re: K051876 Trade/Device Name: MultiWave XR 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: July 6, 2005 Received: July 11, 2005

Dear Dr. Nikolaenko:

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- Gennady L. Nikolaenko, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought interest of your device of your device to a legally premaired 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 in you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, eonater and other of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic 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/dsma/dsmamain.html

Sincerely yours,

Neil R. Snyder

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix C (Indications for Use Statement) 10.3.

Indications for Use Statement

510(k) number: K 0.51876

Device name: MultiWave XR

Indications for use:

The MultiWave XR Laser System is indicated for the following uses:

1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face.
1. The 755 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for I-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1. The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.

V Prescription Use (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilke Bl
(Division Sign-Off) - for mman

Division of General, Restorative, and Neurological Devices

510(k) Number K051876

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.