(88 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on hardware components and pulsed light technology.
No
The device is indicated for hair removal, which is typically considered an aesthetic procedure rather than a therapeutic one aimed at treating a disease or condition for medical benefit.
No
The device description clearly states its intended use is for "removing unwanted hair," and there is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly details hardware components including a cabinet, umbilical, and handpiece, indicating it is not a software-only device.
Based on the provided information, the Plasmalite Pulsed Light System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to remove unwanted hair in all skin types". This is a therapeutic or cosmetic procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a system that delivers pulsed 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 blood, urine, tissue, or any other biological sample. The device interacts directly with the patient's skin.
Therefore, the Plasmalite Pulsed Light System is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Plasmalite Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
Product codes
GEX
Device Description
The Plasmalite 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No Clincal studies were specifically conducted using the Plasmalite. The Plasmalite is technically the exact device as the predicate device, the ProLite. Results from the clinical studies for the ProLite were submitted in 510(K) number 013366.
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.
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Attachment I 510(K) Summary Plasmalite Pulsed Light System
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string is "KO22378". The characters are written in black ink on a white background. There is a line drawn underneath the string.
This 510(K) Summary of safety and effectiveness for the 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 AB. |
|---|---|
| Address: | Lona Knapes gata 5 |
| 421 32 Vastra Frolunda, | |
| Sweden | |
| Contact Person: | Morgan Gustavsson |
| Telephone / Fax / Email | 46.31.709.30.70 - Phone |
| 46.31.709.30.79 - Fax | |
| morgan@medicalbiocare.com | |
| Preparation Date: | July 15, 2002 |
| Device Trade Name: | Plasmalite 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: | ProLite Pulsed Light System, Manufactured by Medical |
| BioCare was previously cleared under 510(K) number | |
| K013366. | |
| Description of the Plasmalite Pulsed Light | |
| System | The Plasmalite 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 Plasmalite Pulsed | |
| Light System | The Plasmalite Pulsed Light System is indicated for use to |
| remove unwanted hair in all skin types according to the | |
| Fitzpatrick Scale. | |
| Performance Data: | No Clincal studies were specifically conducted using the |
| Plasmalite. The Plasmalite is technically the exact device as | |
| the predicate device, the ProLite. Results from the clinical | |
| studies for the ProLite were submitted in 510(K) number |
-
|
| Conclusion: | The Plasmalite Pulsed Light System is substantially
equivalent to other existing pulsed light systems in
commercial distribution for removal of hair in Dermatology
and Plastic Surgery. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT 1 8 2002
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: K022378
Trade/Device Name: Plasmalite Pulsed Light System Regulation Number: 878.4810 Regulation Name: Instrument, surgical, powered, laser Regulatory Class: Class II Product Code: GEX Dated: July 15, 2002 Received: July 22, 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" (21 CFR 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 vours.
Muriam C. Provost
for 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
Rending 510(k) Number:
Device Name: Plasmalite Pulsed Light System
Indications for Use:
The Plasmalite Pulsed Light System is intended to remove unwanted hair for all skin types according to the Fitzpatrick Scale.
(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 K622378