(239 days)
Not Found
No
The summary describes a pulsed light system with filters and a touchscreen interface, but makes no mention of AI or ML capabilities.
Yes
The intended uses listed (removal of unwanted hair, treatment of benign pigmented lesions, removal of tattoos, treatment of vascular lesions, etc.) are all therapeutic in nature, as they involve addressing or alleviating medical conditions or undesirable physical attributes.
No
The device's intended use is for treatments like hair removal, treatment of pigmented lesions, and vascular lesions, not for diagnosing medical conditions.
No
The device description clearly states it is a "Pulsed Light System" composed of a "Tower" and a "Handpiece" containing physical components like a flash lamp, filter, and waveguide. While it has a touchscreen interface, it is fundamentally a hardware device that uses light pulses for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ProLite III TM Pulsed Light System is a light-based device used for dermatological treatments directly on the patient's skin (hair removal, treatment of lesions, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended uses described are all related to treating conditions on the skin surface, not analyzing biological samples.
Therefore, the ProLite III TM Pulsed Light System falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750 - 1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The ProLite III IPL is a device designed for dermatological use. It produces an intense light pulse within the wavelengths of 450 to 2000 nanometers, which is tailored to specific indications by a bandpass filter. The system is composed of a Tower which encloses the power supply and cooling system and a Handpiece which contains the flash lamp, filter and waveguide. The device is controlled by a touchscreen graphic user interface.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO81095
Section 5
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and
807.92. Summary preparation date 04-10-08 [21 CFR 807.92(a)(1)].
Contact Information [21 CFR 807.92(a)(1)] A.
Quantel USA
P O Box 8100
Bozeman, MT 59715
Tel: 406-586-0131
Fax: 406-586-2924
Contact person: Michael Johnson M.D.
B. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: ProLite III Intense Pulsed Light System
Device Common Name: Intense Pulsed Light (IPL)
Classification Name: Laser Instrument, Surgical Powered (per 21 CFR 878.4810)
Product Code: GEX
Panel: Dermatology and Plastic Surgery
Device Classification: Class II
C. Predicate Devices [21 CFR 807.92(a)(3)]
The ProLite III IPL device uses similar technology and has equivalent physical output characteristics as the following predicate devices:
ProLite, manufactured by Big Sky Laser Technologies, now Quantel USA (K021304)
Dermalux, manufactured by Palomar (K010618)
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1
D. Device Description [21 CFR 807.92(a)(4)]
The ProLite III IPL is a device designed for dermatological use. It produces an intense light pulse within the wavelengths of 450 to 2000 nanometers, which is tailored to specific indications by a bandpass filter. The system is composed of a Tower which encloses the power supply and cooling system and a Handpiece which contains the flash lamp, filter and waveguide. The device is controlled by a touchscreen graphic user interface.
E. Device Specifications [21 CFR 807.92(a)(6)]
The ProLite III IPL outputs a flash with selectable pulse durations of 5 to 120 milliseconds with a shot fluence adjustable in the range of 5-30 J/cm². The maximal repetition rate is 1 shot ver second. The photorejuvenation "PR" handpieces output the spectrum from 530 to 1100 nm, 550-1100 nm, or 580-1100 nm using a userinaccessible bandpass filter. The hair removal "HR" handpieces output the spectrum from 630 to 990 nm, 630 to 1100 nm, or 650 to 1100 nm using a user inaccessible bandpass filter. The waveguide area is 6 cm (1.5 x 4 cm). The waveguide is cooled by thermo-electric "Peltier" devices with the temperature setpoint adjustable from room temperature to 5℃.
F. Indications for Use [21 CFR 807.92(a)(5)]
The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750 - 1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.
G. Conclusion [21 CFR 807.92(b)(3)]
Technologically, the ProLite III was found to be substantially equivalent to the currently cleared ProLite (K021303) and Dermalux (K021304). Thus, the risks and benefits for the ProLite III are comparable to the predicate devices.
The indications for use are exactly the same as the previously cleared pulsed light system, the ProLite (K021303).
We believe that there are no new questions of safety or efficacy raised by the introduction of the ProLite III.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quantel USA % Michael Johnson, M.D. 601 Haggerty Lane Bozeman, Montana 59715
DEC 1 2 2008
Re: K081095
Trade/Device Name: ProLite III Regulation Number: 21 CFR 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 17, 2008 Received: October 20, 2008
Dear Dr. Johnson:
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 - Michael Johnson, M.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4
Indications for Use
510(k) Number (if known): _ _ OR 109 S
Device Name: ProLite III
Indications for Use:
The ProLite III M Pulsed Light System with the HR handpiece (containing a 630-1100 nm, or 750-1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 mm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Reost farmer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number