(90 days)
010927
No
The document describes a pulsed light system for hair removal and does not mention any AI or ML components or functionalities.
Yes
The device is specifically indicated to "permanently reduce unwanted hair," which is a therapeutic purpose.
No
The device is indicated for permanent hair reduction, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines hardware components including a cabinet, umbilical, and handpiece, indicating it is a physical device that delivers pulsed light, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to permanently reduce unwanted hair." This is a therapeutic or cosmetic procedure performed on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a pulsed light system that delivers light to the skin. This aligns with a device used for external treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ProLite / Plasmalite MPX Pulsed Light System is indicated to permanently reduce unwanted hair.
The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.
Product codes
GEX
Device Description
The ProLite / PlasmaliteMPX Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power supply and 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
Clinical studies were conducted to provide assurance that difference in the specifications of the ProLite / Plasmalite MPX Pulsed Light System and the predicate device for hair removal did not result in different performance during use. These results were previously reported to the FDA in 510(K) 010927. Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment. There was no scarring in any subject. The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
010927
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
DEC 1 6 2002
Attachment I 510(K) Summary ProLite / Plasmalite MPX Pulsed Light System
んの2308 (
This 510(K) Summary of safety and effectiveness for the ProLite / Plasmalite 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 Nordic AB. |
|---|---|
| Address: | Lona Knapes gata 5 |
| 421 32 Vastra Frolunda, | |
| Sweden | |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax | 46.31.709.30.70 - Phone |
| 46.31.709.30.79 - Fax | |
| Preparation Date: | September 11, 2002 |
| Device Trade Name: | ProLite / Plasmalite MPX Pulsed Light System |
| Common Name: | Pulsed Light for Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | EpiLight / Photoderm HR System |
| K number K991935 | |
| Description of the ProLite / Plasmalite | |
| MPX Pulsed Light System | The ProLite / PlasmaliteMPX Pulsed Light System delivers |
| pulsed light at a wavelength beginning at a wavelength of | |
| 600 nm. The device consists of three interconnected | |
| sections: The cabinet which houses the internal cooling | |
| system, power supply and 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 to permanently reduce unwanted hair. | |
| Performance Data: | Clinical studies were conducted to provide assurance that |
| difference in the specifications of the ProLite / Plasmalite | |
| MPX Pulsed Light System and the predicate device for hair | |
| removal did not result in different performance during use. | |
| These results were previously reported to the FDA in 510(K) | |
| 010927 | |
| Results of Clinical Study: | Observation in the clinical study were recorded prior to |
| treatment and at 3-6 months after treatment. There was no | |
| scarring in any subject. | |
| The study demonstrated that selective photothermolysis | |
| targeting melanin in the human hair follicle is an effective | |
| tool for hair removal. | |
| Conclusion: | The ProLite / Plasmalite MPX Pulsed Light System is |
| substantially equivalent to other existing pulsed light | |
| systems in commercial distribution for permanent hair | |
| reduction in Dermatology and Plastic Surgery. |
1
Attachment I 510(K) Summary ProLite / Plasmalite MPX Pulsed Light System
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Bio Care Sweden AB c/o Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K023081
Trade/Device Name: Plasmalite Pulsed Light System for Permanent Reduction of Unwanted Hair
Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered laser Regulatory Class: Class II Product Code: GEX Dated: September 12, 2002 Received: September 17, 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
3
Page 2 - Ms. Connie White Hoy
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.
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). 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,
Miriam C. Provost
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k)
Number: | Pending
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|-------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Device Name: ProLite / Plasmalite MPX Pulsed Light System
Indications for Use:
The ProLite / Plasmalite MPX is intended to be used for the permanent reduction of unwanted hair.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (per 21 CFR 801.109)
OR
Over-the-Counter Use
Muriam C Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023081