(90 days)
Not Found
No
The description focuses on the laser technology and control system, with no mention of AI or ML.
Yes
The device is described for the "Treatment of benign pigmented lesions," indicating a therapeutic purpose to address and manage medical conditions.
No
The device description and intended use focus on treatment (e.g., "Treatment of benign pigmented lesions") using pulsed energy to cause a therapeutic effect. There is no mention of the device being used to detect, diagnose, or monitor a condition.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, optical delivery system, and handpiece, in addition to the software control system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of benign pigmented lesions." This describes a therapeutic action performed directly on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a laser system that delivers energy to the skin. This is consistent with a therapeutic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measuring biomarkers or analytes
- Providing diagnostic information about a patient's health status
In summary, the device's function is to treat a condition on the skin using laser energy, which falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GentleLASE Family of lasers is indicated for use for the treatment of benign pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber/handpiece delivery system. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The GentleLASE Family of Laser Systems are designed with six major components:
- ]. High voltage power supply and modulator system
- Optical laser head 2.
-
- Circulator system
-
- Optical delivery system
- Software control system
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
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)
As laser products, the GentleLASE Family of laser Systems are required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2. Part 2 established by and required by the European Community. The indications for use for the treatment of benign pigmented lesions is based on a controlled clinical study using a device that has been cleared for use in the market.
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.
Candela GentleLASE GL (K994260)
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
MAR 3 1 2003
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters appear to be 'K024371'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.
General Information:
This 510/k) is to provide notification of substantial equivalence for the Candela GentleLASE Family of Laser Systems, which is substantially equivalent to previously marketed devices . The GentleLASE Family of lasers is indicated for use for the treatment of benign pigmented lesions.
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William H. McGrail |
| Date prepared: | December 30, 2002 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in
General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, GentleLASE Family of Laser Systems |
| Predicate Devices: | Candela GentleLASE GL (K994260) |
Description:
The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber/handpiece delivery system. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The GentleLASE Family of Laser Systems are designed with six major components:
- 】. High voltage power supply and modulator system
- Optical laser head 2.
-
- Circulator system
-
- Optical delivery system
- న్. Software control system
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
1
Testing:
As laser products, the GentleLASE Family of laser Systems are required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2. Part 2 established by and required by the European Community.
Safety and Effectiveness Information:
The indications for use for the treatment of benign pigmented lesions is based on a controlled clinical study using a device that has been cleared for use in the market. We therefore believe that there are no questions of safety or effectiveness raised by the introduction of the Candela GentleLASE Family of Laser Systems.
Summary of Substantial Equivalence:
The Candela GentleLASE Family of Laser Systems have the same intended use, utilizes similar operating principles, design aspects, spot size, wavelength, and fluence as the predicate devices.
On the basis of similarities in methods of assembly, method of operation, and intended uses. Candela Corporation believes that the Candela GentleLASE Family of Laser Systems is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2003
Mr. William H. McGrail Vice President of Research & Development and Operations Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778-1886
Re: K024371
Trade/Device Name: Candela GentleLASE Family of Laser Systems 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: December 30, 2002 Received: December 31, 2002
Dear Mr. McGrail:
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 - Mr. William H. McGrail
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) you may obtain. 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,
Muriam C. Provost
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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is partially filled with diagonal lines, and the word "CANDELA" is in a simple, sans-serif font.