(27 days)
No
The summary describes a pulsed light system with a microcontroller, power supply, and cooling system. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes.
The device is intended for the "treatment of vascular lesions," which indicates a therapeutic purpose.
No
The device is described as a treatment device for vascular lesions, not one used for diagnosis.
No
The device description explicitly details hardware components including a cabinet, power supply, cooling system, microcontroller, umbilical, handpiece, and waveguide.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treatment of vascular lesions." This is a therapeutic application, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The description details a pulsed light system used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), image processing for diagnostic purposes, or any other typical characteristics of an IVD.
The device is a therapeutic device used in dermatology and plastic surgery for treating vascular lesions.
N/A
Intended Use / Indications for Use
The Prolite / Plasmalite MPX Pulsed Light System is indicated for the treatment of vascular lesions.
The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.
Product codes
GEX
Device Description
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
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)
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 5 |
| 421 32 Vastra Frolunda, | |
| Sweden | |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone |
| 46.31.709.30.79 - Fax | |
| morgan@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, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | ProLite Pulsed Light System |
| K number 010928 | |
| Description of the Prolite / Plasmalite | |
| MPX Pulsed Light System | 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 | |
| Intended use of the Prolite / Plasmalite | |
| MPX Pulsed Light System | The Prolite / Plasmalite MPX Pulsed Light System is |
| indicated for the treatment of vascular lesions. | |
| Performance Data: | None |
| Conclusion: | The ProLite / Plasmalite MPX Pulsed Light System is |
| substantially equivalent to other existing pulsed light | |
| systems in commercial distribution for treatment of vascular | |
| lesions in Dermatology and Plastic Surgery. |
1
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.
2
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
3
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)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Styt Plurde
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_KOZZS69