PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS by MEDICAL BIO CARE SWEDEN AB

The Prolite / Plasmalite MPX Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide

AI/ML Overview

The provided document (K022569/A) states under "Performance Data:" that there is "None". Therefore, the remaining requested information regarding acceptance criteria and study details cannot be extracted from this submission.

Here is the table that can be created based on the available information:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Further information regarding the study:

Sample size used for the test set and the data provenance: Not applicable, as no performance data or study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pulsed light system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The submission focuses solely on demonstrating substantial equivalence to a predicate device (ProLite Pulsed Light System, K number 010928) based on its design, intended use (treatment of vascular lesions), and technical specifications (delivers pulsed light at 550 nanometers). It does not include any clinical performance data or studies.

Summary

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DUPLICATE

K022569/A'

AUG 2 9 2002

Attachment I 510(K) Summary Prolite / Plasmalite MPX Pulsed Light System

This 510(K) Summary of safety and effectiveness for the Prolite / Plasmalite MPX Pulsed Light System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Medical Bio Care AB
Address:	Lona Knapes gata 5421 32 Vastra Frolunda,Sweden
Contact Person:	Morgan Gustafsson
Telephone / Fax / Email	46.31.709.30.70 - Phone46.31.709.30.79 - Faxmorgan@medicalbiocare.com
Preparation Date:	August 11, 2002
Device Trade Name:	Prolite / Plasmalite MPX Pulsed Light System
Common Name:	Pulsed Light for Photothermolysis
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-48
Legally Marketed Predicate Device:	ProLite Pulsed Light SystemK number 010928
Description of the Prolite / PlasmaliteMPX Pulsed Light System	The Prolite / Plasmalite MPX Pulsed Light System deliverspulsed light at a wavelength of 550 nanometers. The deviceconsists of three interconnected sections: The cabinet whichhouses the power supply, the cooling system and themicrocontroller, the umbilical to the handpiece, and thehandpiece, which houses the waveguide
Intended use of the Prolite / PlasmaliteMPX Pulsed Light System	The Prolite / Plasmalite MPX Pulsed Light System isindicated for the treatment of vascular lesions.
Performance Data:	None
Conclusion:	The ProLite / Plasmalite MPX Pulsed Light System issubstantially equivalent to other existing pulsed lightsystems in commercial distribution for treatment of vascularlesions in Dermatology and Plastic Surgery.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2002

Medical Bio Care Sweden AB c/o Connie White Hoy 908 Stetson Street Woodland, California 95776

Re: K022569

Trade/Device Name: ProLite/Plasmalite MPX Pulsed Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 25, 2002

Received: August 2, 2002

Dear Ms. Hoy :

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 - Ms. Connie White Hoy

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 yours,

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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INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ K022569

Device Name: ProLite / Plasmalite MPX Pulsed Light System

Indications for Use:

The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Styt Plurde
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_KOZZS69

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.