The ARION is a 755 nm solid-state long-pulsed Alexandrite laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device. The EPI Zoom Ax transmission system consists of a hand piece attachment with a firmly attached fiber and a hand piece. The hand piece insert can be moved within the hand piece and determine the application and parameter ranges. The hand piece insert in the transmission system hand piece can snap into various positions. The number located closest to the hand piece indicates the spot diameter on the skin in mm (spot sizes: 6/8/10/12/14 mm). The integrated hand piece detection feature automatically shows the selected spot diameter on the laser display. The parameter range is also automatically adjusted for the corresponding range. The MedArt 928 scanner for ARION consists of a scanner with a connected transmission system and a spacer with a 8, 9, 10 and 12 mm spot size. The spacer determines the spot diameter on the skin and therefore the parameter range of the configurable energy densities as well. The spacers are inserted into the scanner as shown below and must be inserted into the scanner up to the limit stop position. The spacers now automatically sets a spot diameter of 8, 9, 10, and 12 mm on the skin; this is also shown automatically on the laser display. The parameter range is also automatically adjusted for the corresponding range. For epidermal cooling can be a cooling device adapted to the handpiece / scanner.

AI/ML Overview

The provided text is a 510(k) summary for the Wavelight Arion device. A 510(k) summary typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

Based on the provided document, here's what can be extracted and what is explicitly stated as not presented:

Acceptance Criteria and Device Performance (Not presented)

The document explicitly states: "6. Performance Data None presented." This means that acceptance criteria and reported device performance against those criteria are not included in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, not on new performance data.

Therefore, the following table cannot be filled from the provided text:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Here's an analysis of the other requested information:

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable/Not provided, as no performance data or test set is mentioned.
Data provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided, as no test set or ground truth establishment is mentioned.

4. Adjudication method for the test set:

Not applicable/Not provided, as no test set or adjudication is mentioned.

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:

No MRMC comparative effectiveness study was done or reported. This device is a laser system for hair removal, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

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

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

7. The type of ground truth used:

Not applicable/Not provided, as no performance data or ground truth is mentioned. The submission is based on substantial equivalence.

8. The sample size for the training set:

Not applicable/Not provided, as no machine learning model or training set is mentioned.

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

Not applicable/Not provided, as no machine learning model or training set is mentioned.

In summary: The 510(k) submission for the Wavelight Arion device explicitly states "Performance Data None presented." This implies that the device achieved marketing clearance through demonstrating substantial equivalence to predicate devices rather than by submitting new clinical or performance data against specific acceptance criteria. Therefore, most of the requested information, which pertains to performance studies and data, is not available in the provided document.

Summary

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Wavelight Arion: 510(k) Review August 31, 2004

SEP 2 9 2004

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510K Summary

WaveLight®
510(k) Summary of Safety and Effectiveness - ARION Device

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

1. General Information
Submitter:	WaveLight Laser Technologie, AGAm Wolfsmantel 591058 ErlangenGermany
Contact Person:	Alexander PoppWaveLight Laser Technologie, AGAm Wolfsmantel 591058 ErlangenGermany
Summary Preparation Date:	July 30, 2004
2. Names
Device Name:	ARION
Classification Name:	Laser Instrument, Surgical PoweredProduct Code: GEXPanel: Dermatology and Plastic Surgery

3. Predicate Devices

The ARION laser system is substantially equivalent to the Light Age Epicare Model LPX (K983977), the Sharplan EpiTouch 5000 Alexandrite laser system (K971874), the Sharplan EpiTouch 5000 Alexandrite laser system (K973354), the Candela Gentlelase family of laser systems (K024260), the Candela Gentlelase family of laser systems (K024335), the Candela Gentlelase GL (K994260), the Cynosure Apogee-Tks II (K031488), and the Cynosure Apogee-Tks (K992757).

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K042474
p. 2 of 2

Wavelight Arion: 510(k) Review August 31, 2004

510K Summary (con't)

510(k) Summary of Safety and Effectiveness - ARION Device

4. Device Description

5. Indications for Use

The ARION laser system is indicated:

The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

1. Performance Data None presented.

0025

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

Public Health Service

SEP 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WaveLight Laser Technologie, AG c/o Mr. William J. Sammons Conformity Assessment Services Underwriters Laboratories, Inc 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K042474 Trade/Device Name: ARION 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: August 31, 2004 Received: September 13, 2001

Dear Mr. Sammons:

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 for association 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 - William J. Sammons

This letter will allow you to begin marketing your device as described in your Section 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), please 11 you a 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/dsma/dsmamain.html

Sincerely yours,

Miriam 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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Wavelight Arion: 510(k) Review August 31, 2004

Indication for use

S WaveLight®

K042474

510 (k) Indication for Use

510(k) Number (if known)

Device Name___________________________________________________________________________________________________________________________________________________________________ ARION

Indications for Use:

The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

Prescription Use(Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

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510(k) Number K042474

0023

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.