(90 days)
K 010927
No
The summary describes a pulsed light system for hair removal and does not mention any AI or ML components or functionalities.
No.
The stated indication for use is "hair removal," which is generally considered an aesthetic or cosmetic procedure, not a therapeutic one aimed at treating a disease or medical condition.
No
The device is indicated for hair removal, which is a treatment, not a diagnostic purpose. It does not identify or detect any disease or condition.
No
The device description explicitly details hardware components including a cabinet, umbilical, and handpiece, indicating it is a physical device, not software-only.
Based on the provided information, the ProLite 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.
- Device Description: The description details a system that delivers pulsed light externally to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. The ProLite Pulsed Light System does not fit this description.
N/A
Intended Use / Indications for Use
The ProLite 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 ProLite 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 sypply 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 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)
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 ProLite Pulsed Light System
K613366
This 510(K) Summary of safety and effectiveness for the ProLite 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 Sweden 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: | September 22, 2001 |
| Device Trade Name: | ProLite 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 K974536 | |
| Description of the ProLite Pulsed Light | |
| System | The ProLite 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 sypply and | |
| microcontroller, the umbilical to the handpiece, and the | |
| handpiece, which houses the waveguide | |
| Intended use of the ProLite Pulsed Light | |
| System | The ProLite Pulsed Light System is indicated for use to |
| remove unwanted hair in all skin types according to the | |
| Fitzpatrick Scale. | |
| Performance Data: | Clinical studies were conducted to provide assurance that |
| difference in the specifications of the ProLite 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. |
1
Attachment I 510(K) Summary ProLite Pulsed Light System
Observation in the clinical study were recorded prior to Results of Clinical Study: 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. The ProLite Pulsed Light System is substantially equivalent Conclusion: to other existing pulsed light systems in commercial distribution for removal of hair in Dermatology and Plastic Surgery.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical BioCare Sweden AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
'JAN 0 8 2002
Re: K013366
Trade/Device Name: ProLite Pulsed Light System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX
Dated: September 22, 2001 Received: October 10, 2001
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.
3
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,
Stept Rhodes
S. Colin McWhirter, Ph.D., M.D.
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
4
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,
Stepten Rhodes
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
5
INDICATION FOR USE STATEMENT
510(k) Number: ____ Pending _ KO1336b ________________________________________________________________________________________________________________________________________
Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________
Indications for Use:
The ProLite 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)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K013366 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |