(133 days)
Not Found
No
The description focuses on the laser technology and hardware components, with no mention of AI or ML.
Yes
The device is used for "photocoagulation of dermatological vascular lesions," which is a treatment for a medical condition.
No
The device description clearly states its purpose is for "photocoagulation of dermatological vascular lesions," which is a treatment, not a diagnostic, function.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, circulator system, and optical delivery system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "photocoagulation of dermatological vascular lesions." This describes a therapeutic procedure performed directly on the patient's body, not a 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 diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.
Product codes
GEX
Device Description
The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with four major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
The Candela Gentlelase Lasers 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
Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.
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.
0
DEC - 4 1997
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Gentlelase GL Laser System, which is substantially equivalent to previously marketed devices intended for the photocoagulation of dermatological vascular lesions.
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in
General and Plastic Surgery and in Dermatology) |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Longpulse Alexandrite Laser |
| Predicate Device: | Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)
notification number K963094 |
Description:
The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with four major components:
-
- High voltage power supply and modulator system
-
- Optical laser head
-
- Circulator system
-
- Optical delivery system
The Candela Gentlelase Lasers 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.
The intended use of the device is for the photocoagulation of dermatological vascular lesions.
Testing:
Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.
Summary of Substantial Equivalence:
The Candela Gentlelase Lasers have the same intended use, utilize the same operating principles and match key design aspects, including similar spotsize, the same wavelength and the same maximum delivered power as the predicate device.
On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Gentlelase lasers are substantially equivalent to previously cleared Candela Q-Switched Alexandrite Lasers and in similarity of intended use and in performance specification equivalent to the Cynosure Photogenica LP Laser.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to suggest a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
DEC - 4 1997
Re: K972767
Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997
Dear Mr. Caplan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
2
Page 2 - Mr. Caplan
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
tballa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEC - 4 1997
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Gentlelase GL Laser System, which is substantially equivalent to previously marketed devices intended for the photocoagulation of dermatological vascular lesions.
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in
General and Plastic Surgery and in Dermatology) |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Longpulse Alexandrite Laser |
| Predicate Device: | Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)
notification number K963094 |
Description:
The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with four major components:
-
- High voltage power supply and modulator system
-
- Optical laser head
-
- Circulator system
-
- Optical delivery system
The Candela Gentlelase Lasers 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.
The intended use of the device is for the photocoagulation of dermatological vascular lesions.
Testing:
Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.
Summary of Substantial Equivalence:
The Candela Gentlelase Lasers have the same intended use, utilize the same operating principles and match key design aspects, including similar spotsize, the same wavelength and the same maximum delivered power as the predicate device.
On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Gentlelase lasers are substantially equivalent to previously cleared Candela Q-Switched Alexandrite Lasers and in similarity of intended use and in performance specification equivalent to the Cynosure Photogenica LP Laser.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
DEC - 4 1997
Re: K972767
Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997
Dear Mr. Caplan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
5
Page 2 - Mr. Caplan
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
tballa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K972 j10(k) Number (if known):
Device Name: Candela GentleLase GL Dermatology Vascular Lesion Laser
Indications For Use:
The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (SDE)
Division of General Restorative Devices
510(k) Number: 272767
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
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