K Number

Device Name

MEDLITE Q-SWITHCED LASER

Manufacturer

CONTINUUM ELECTRO-OPTICS, INC.

Date Cleared

2003-02-20

(190 days)

Product Code

GEX

Regulation Number

878.4810

Intended 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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K971207, K983054

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology and its physical parameters, mentioning "Microprocessor Control" but no specific AI/ML capabilities. There is no mention of AI, ML, deep learning, image processing, or any data-driven performance metrics typically associated with AI/ML devices.

Therapeutic

No.
The device is used for surgical procedures and skin resurfacing, which are treatments, but it is not explicitly labeled as a "therapeutic device" in the provided information.

Diagnostic

The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation, hemostasis, and laser skin resurfacing procedures for the treatment of acne scars and wrinkles. These are therapeutic applications, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components such as a laser medium, power supply, handpiece, and articulated arm, indicating it is a physical laser system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "dermatologic and general surgical procedures for coagulation and hemostasis" and "laser skin resurfacing procedures for the treatment of acne scars and wrinkles." These are all procedures performed on the patient's body, not on samples taken from the body.
Device Description: The description details a laser system designed to deliver energy to tissue. This is consistent with a surgical or dermatological device, not a device that analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly interact with tissue for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

79GEX

Device Description

The Medlite Q-Switched Laser is described as a "Surgical Laser" or "Instrument, Surgical, Powered, Laser." It is a Nd:YAG laser system that uses a Q-Switched pulse method. It has a maximum power of 30 Watts and emits light at wavelengths of 1064 and 532 nm. The pulse rate can be set to 1, 2, 5, 10, or single shot, with a pulse duration of less than 20 nanoseconds. Beam delivery is achieved via a handpiece using an articulated arm, and the beam quality is multimode. The device is microprocessor controlled. It operates on 110/120 VAC - 50/60 Hz or 220/240 VAC - 50/60 Hz power supply.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K971207, K983054

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

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.

Summary

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. | Identical

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.

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

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