The Medlite Q-Switched Laser is a laser device with a Nd:YAG laser medium, Q-Switched pulse method, Max Power of 30 Watts, Wavelength of 1064 & 532, Power Supply of 110/120 VAC - 50/60 Hz and 220/240 VAC - 50/60 Hz, Pulse Rate of 1, 2, 5, 10, Single Shot, Pulse Duration (nsec) of Less than 20, Beam Delivery via Handpiece using articulated arm, Multimode Beam Quality, and Microprocessor Control.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Medlite Q-Switched Laser. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study for meeting specific acceptance criteria in the context of diagnostics or AI performance. Therefore, detailed information typically found in clinical studies assessing device performance against acceptance criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth) is not present in this document.

The "acceptance criteria" here are implicit in demonstrating substantial equivalence: the proposed device's features and indications for use must be similar enough to a predicate device.

Here's an attempt to extract relevant information given the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as a comparison of specifications and intended use against a predicate device. The "reported device performance" is essentially the listed specifications of the proposed device, which are shown to be identical or sufficiently similar to the predicate.

Feature / Acceptance Criteria (Comparison Point)	Medlite Q-Switched Laser (K022709, Proposed Device)	Medlite Q-Switched Laser (K014234, Predicate 1)	ThermoLase Laser (K971207, Predicate 2)	Substantially Equivalent? (Yes/No)
Indications For Use:	For use in dermatologic and general surgical procedures for coagulation and hemostasis. For use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.	Identical (for coagulation and hemostasis). Not indicated for acne scars and wrinkles.	Identical (for coagulation and hemostasis).	Yes (with a note for K014234 on resurfacing)
Laser Medium:	Nd:YAG	Nd:YAG	Nd:YAG	Yes
Pulse Method:	Q-Switched	Q-Switched	Q-Switched	Yes
Max Power:	30 Watts	30 Watts	30 Watts	Yes
Wavelength:	1064 & 532 nm	1064 & 532 nm	1064 nm	Yes (predicate 2 only 1064, but overall equivalence established)
Power Supply:	110/120 VAC - 50/60 Hz; 220/240 VAC - 50/60 Hz	110/120 VAC - 50/60 Hz	117/230 VAC - 50/60 Hz	Yes
Pulse Rate:	1, 2, 5, 10 Hz, Single Shot	1, 2, 5, 10 Hz, Single Shot	1, 2, 5, 10 Hz, Single Shot	Yes
Pulse Duration (nsec):	Less than 20	Less than 20	6-20	Yes (within comparable range)
Beam Delivery:	Handpiece using articulated arm	Handpiece using articulated arm	Handpiece using articulated arm	Yes
Beam Quality:	Multimode	Multimode	Multimode	Yes
Microprocessor Control:	Yes	Yes	Yes	Yes

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

This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data. Therefore, there is no information on a clinical test set sample size or data provenance. The "test" here involves comparing device specifications.

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

Not applicable. "Ground truth" in the sense of clinical annotations by experts is not established for this type of submission. The "ground truth" for the comparison is the published specifications of the predicate devices.

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

Not applicable. There is no clinical test set requiring adjudication.

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 is not an AI device, and no MRMC study was performed or reported.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this substantial equivalence claim is the technical specifications and indications for use of legally marketed predicate devices (K971207 and K983054). The comparison is based on documented features rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is involved.

Summary

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022709

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Device Name:
Trade Name:	Medlite Q-Switched Laser
Common Names:	Surgical Laser
Classification Name:	Instrument, Surgical, Powered, Laser	FEB 2 0 2003

Establishment Name & Registration Number: 2. Name: Hova-ConBio, Inc. Number: Pending

3. Classification:

Title 21. Code of Federal Regulations.

Sec. 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 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 Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

ProCode: 79GEX

4. Guidance Documents. Performance Standards and Special Controls:

At the present time, the following guidance documents are in effect for this device:

Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

Compliance Guide for Laser Products (FDA 86-8260)

Laser Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50)

FDA mandated performance standards for this device exist and are specified under 21 CFR, $1010. These standards, including OSR required as required by regulation. Voluntary standards such as UL, in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the Medlite O-Switched Laser.

Equivalent Device(s): 5.

The Medlite Q-Switched Laser claims substantial equivalence to the Thermolase SoftLight Laser, K971207 and the Medite () Switched Laser previously cleared via K983054. A feature comparison table is included on the following page for visual comparison of equivalence factors.

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Applicant/Sponsor Name / Address: 6.

Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

7. Company Contact:

Mr. Dan Romitelli Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

Submission Correspondent: જે.

David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 fax david(@fda-help.com

9. Manufacturing Facility:

Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

Description of the Device and Indications for Use: 10.

Feature	Medlite Q-Switched Laser	Medlite Q-Switched Laser, K014234	ThermoLase Laser, K971207	SoftLight SE?
Indications For Use:	The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for ecoagulation and hemostasis.The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.	IdenticalNo	Identical	Yes
Laser Medium:	Nd:YAG	Nd:YAG	Nd:YAG	Yes
Pulse Method:	Q-Switched	Q-Switched	Q-Switched	Yes
Max Power:	30 Watts	30 Watts	30 Watts	Yes
Wavelength:	1064 & 532	1064 &532	1064	Yes
Power Supply:	110/120 VAC - 50/60 Hz220/240 VAC - 50/60 Hz	110/120 VAC - 50/60 Hz	117/230 VAC - 50/60 Hz	Yes
Pulse Rate:	1, 2, 5, 10, Single Shot	1, 2, 5, 10, Single Shot	1, 2, 5, 10, Single Shot	Yes
Pulse Duration (nsec):	Less than 20	Less than 20	6-20	Yes
Beam Delivery:	Handpiece using articulated arm	Handpiece using articulated arm	Handpiece using articulated arm	Yes
Beam Quality:	Multimode	Multimode	Multimode	Yes
Microprocessor Control:	Yes	Yes	Yes	Yes
Manufacturer:	Hoya-ConBio, Inc.	Continuum Electro-Optics, Inc.	ThermoLase Corporation	Yes

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Hoya-ConBio, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Pleasant Hill, California 94523-3389

Re: K022709

Trade/Device Name: Medlite O-Switched Laser 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: December 15, 2002 Received: December 31, 2002

Dear Mr. Schlerf:

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 - Mr. David W. Schlerf

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 contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 vours.

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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510(k) NUMBER: K022709

DEVICE NAME : Medlite Q-Switched Laser

INDICATIONS FOR USE:

The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis.

The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General. Restorative and Neurologi . . . evices

810(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use /
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

MedliteResponse2.doc

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.