(82 days)
Not Found
No
The description focuses on the laser technology, optical delivery system, and a cooling device. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is indicated for "photocoagulation of dermatological vascular lesions," which is a treatment for a medical condition. Additionally, the integrated cooling device is intended for "reduction of pain," further supporting its therapeutic nature.
No
The device description and intended use indicate that the Candela Gentlelase GL Dermatology Laser is used for photocoagulation of dermatological vascular lesions and for cooling the skin. These are treatment functions, not diagnostic functions. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly outlines multiple hardware components including an Alexandrite rod, optical fiber/handpiece delivery system, high voltage power supply, optical laser head, circulator system, and the Dynamic Cooling Device with its own hardware components (source of fluid, solenoid valve, electronic timing circuitry). While it mentions a "Software control system," this is listed as one component among many hardware components that constitute the overall laser system.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Candela Gentlelase GL Dermatology Laser is a laser system that directly interacts with the patient's skin for the photocoagulation of dermatological vascular lesions. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The stated intended uses are for treating vascular lesions and reducing pain/cooling the skin during treatment. These are therapeutic and comfort-related applications, not diagnostic ones.
- Device Description: The description details the laser's components and how it delivers energy to the skin. There is no mention of analyzing biological samples.
Therefore, the Candela Gentlelase GL Dermatology Laser falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Candela Gentlelase GL Dermatology Laser is indicated for the following uses:
- the photocoagulation of dermatological vascular lesions.
The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:
- the reduction of pain.
- cooling of skin prior to laser treatment.
Product codes
GEX
Device Description
The Candela (Modified) Gentlelase GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with five major components:
- High voltage power supply and modulator system.
- Optical laser head.
- Circulator system.
- Optical delivery system.
- Software control 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 Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates.
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)
Testing of the GentleLase Laser System, including the Dynamic Cooling Device, consists of component testing and functional testing of the completed Laser.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
FEB 10 1998 74381
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela (Modified) 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, Long pulse Alexandrite Laser |
| Predicate Device: | Candela Gentlelase GL laser cleared under 510(k) 972767. |
Description:
The Candela (Modified) Gentlelase GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with five major components:
- High voltage power supply and modulator system 1.
- Optical laser head 2.
- Circulator system 3.
-
- Optical delivery system
- Software control system 5.
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 laser system is for the photocoagulation of dermatological vascular lesions.
The Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates.
The intended use of the Dynamic Cooling Device is to cool the skin prior to laser treatment, to minimize thermal damage to skin during laser treatment and to reduce pain associated with laser treatment.
Testing:
Testing of the GentleLase Laser System, including the Dynamic Cooling Device, 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.
1
The Dynamic Cooling Device, which is part of the Candela GentleLase Laser System, has the same intended use, utilizes the same operating principles, and has the same technological and performance characteristics as the predicate device, the Candela Dynamic Cooling Device.
On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela On the basis of similaries in modified) Gentle Lase System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
FEB 1 0 1998
Re: K974381
Trade Name: Candela (Modified) GentleLase GL Dermatological Laser Regulatory Class: II Product Code: GEX Dated: November 17, 1997 Received: November 20, 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 (OS) 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 not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Mr. Caplan
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,
Ascella
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
4
510(k) Number (if known): ----------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Candela (Modified) GentleLase GL Dermatology Laser
Indications For Use:
Prescription Use (Per 21 CFR 801.109)
The Candela Gentlelase GL Dermatology Laser is indicated for the following uses:
- the photocoagulation of dermatological vascular lesions.
The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain.
- cooling of skin prior to laser treatment.
(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 Devices | |
| 510(k) Number | K97438/ |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------ | ---- | ---------------------- |
(Optional format 1-2-96)