(90 days)
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.
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
Below is an analysis of the provided text regarding the ProLite / Plasmalite MPX Pulsed Light System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(K) Summary for ProLite / Plasmalite MPX Pulsed Light System) focuses on demonstrating "substantial equivalence" to a predicate device rather than setting explicit, quantifiable "acceptance criteria" in the typical sense of a clinical trial's primary endpoint. The primary outcome discussed relates to the intended use of the device, which is "to permanently reduce unwanted hair."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Permanent reduction of unwanted hair (efficacy) | "The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal." |
| Safety Profile | "There was no scarring in any subject." |
| Equivalence to predicate device | The ProLite / Plasmalite MPX Pulsed Light System is considered "substantially equivalent to other existing pulsed light systems in commercial distribution for permanent hair reduction in Dermatology and Plastic Surgery." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of subjects in the clinical study. It generically states "Clinical studies were conducted" and "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. The efficacy is described as being observed (e.g., reduction of hair, absence of scarring), but the method of assessment for this observation (e.g., expert clinical assessment, objective measurement) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set results.
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
This section is not applicable. The device is a pulsed light system for hair removal, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical medical device (pulsed light system) and does not involve an algorithm working in a "standalone" capacity in the sense of AI performance. Its performance is directly tied to its physical application by a human operator.
7. The Type of Ground Truth Used
The "ground truth" for the efficacy of the hair removal system appears to be clinical observation/outcomes data. The document states:
- "Observation in the clinical study were recorded prior to treatment and at 3-6 months after treatment."
- "The study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal."
- "There was no scarring in any subject."
This indicates that the effectiveness and safety were assessed directly from the patients' responses to the treatment.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical pulsed light system and does not involve a "training set" in the context of machine learning or AI algorithms. The "clinical studies" mentioned are for validation/testing, not for training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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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 5421 32 Vastra Frolunda,Sweden |
| Contact Person: | Morgan Gustafsson |
| Telephone / Fax | 46.31.709.30.70 - Phone46.31.709.30.79 - 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, laser79-GEX, 21 CFR 878-48 |
| Legally Marketed Predicate Device: | EpiLight / Photoderm HR SystemK number K991935 |
| Description of the ProLite / PlasmaliteMPX Pulsed Light System | The ProLite / PlasmaliteMPX Pulsed Light System deliverspulsed light at a wavelength beginning at a wavelength of600 nm. The device consists of three interconnectedsections: The cabinet which houses the internal coolingsystem, power supply and microcontroller, the umbilical tothe handpiece, and the handpiece, which houses thewaveguide |
| Intended use of the ProLite / PlasmaliteMPX Pulsed Light System | The ProLite / Plasmalite MPX Pulsed Light System isindicated to permanently reduce unwanted hair. |
| Performance Data: | Clinical studies were conducted to provide assurance thatdifference in the specifications of the ProLite / PlasmaliteMPX Pulsed Light System and the predicate device for hairremoval 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 totreatment and at 3-6 months after treatment. There was noscarring in any subject. |
| The study demonstrated that selective photothermolysistargeting melanin in the human hair follicle is an effectivetool for hair removal. | |
| Conclusion: | The ProLite / Plasmalite MPX Pulsed Light System issubstantially equivalent to other existing pulsed lightsystems in commercial distribution for permanent hairreduction in Dermatology and Plastic Surgery. |
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Attachment I 510(K) Summary ProLite / Plasmalite MPX Pulsed Light System
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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
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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
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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
§ 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.