(90 days)
K60772
Not Found
No
The summary describes a pulsed light system with standard components (power supply, cooling, microcontroller, handpiece) and makes no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the treatment of benign pigmented lesions and the removal of tattoos, which are therapeutic applications.
No
The device is indicated for the treatment of benign pigmented lesions and tattoo removal, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, and microcontroller, an umbilical, and a handpiece housing a waveguide. This is not a software-only device.
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 for the treatment of benign pigmented lesions and the removal of tattoos. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that delivers pulsed light to the body. This is consistent with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the ProLite Pulsed Light System falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos.
The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.
Product codes
GEX
Device Description
The ProLite 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Photoderm PL System K60772
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
JAN 8 2002
This 510(K) Summary of safety and effectiveness for the ProLite VL 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.
Lona Knapes gata 5 421 32 Vastra Frolunda,
Morgan Gustafsson
46.31.709.30.70 - Phone
ProLite Pulsed Light System
Intense Pulsed Light System
79-GEX, 21 CFR 878-48
Photoderm PL System
houses the waveguide
K number K60772
Instrument, Surgical, Powered, laser
46,31.709.30.79 - Fax morgan@medicalbiocare.com
October 5, 2001
Sweden
Applicant:
Medical Bio Care Sweden AB.
Address:
Contact Person:
Telephone / Fax / Email
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Description of the ProLite V Pulsed Light System
Intended use of the ProLite V Pulsed Light System
Performance Data:
Conclusion:
None The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and
the removal of tattoos in Dermatology and Plastic Surgery.
The ProLite Pulsed Light System delivers pulsed light at a
wavelength of 550 nanometers. The device consists of three
The ProLite Pulsed Light System is indicated the treatment
of benign pigmented lesions and the removal of tattoos.
interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the outer edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 8 2002
Medical BioCare Sweden AB c/o Ms. Connie White Hoy 908 Stetson Street Woodland, California 95776
Re: K013365
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: October 1, 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.
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,
Stupt Rhodes
Colie M. Witten, 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
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Koj3365//A'
INDICATION FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: ProLite Pulsed Light System______________________________________________________________________________________________________________________________________
Indications for Use:
The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.
(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 Gener, Restorative and Neurological Devices | |
|---|---|---|
| 510(k) Number | K013365 | |
| Prescription Use | ||
| (per 21 CFR 801.109) | OR | Over-the-Counter Use |