(38 days)
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No
The document describes a laser device with a software control system and cooling device, but there is no mention of AI or ML capabilities.
Yes
The device is used for photocoagulation of dermatological vascular lesions and hair removal, which are therapeutic interventions. Additionally, its cooling device reduces pain, which is also a therapeutic function.
No
The device description and intended uses clearly state that it is a dermatology laser for treatment (photocoagulation and hair removal), not for diagnosis.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, optical delivery system, and a dynamic cooling device, in addition to the software control system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 II Dermatology Laser is a laser system that applies energy directly to the patient's skin for therapeutic purposes (photocoagulation of vascular lesions and hair removal). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are for treating conditions on the skin, not for analyzing biological samples.
Therefore, based on the provided information, the Candela GentleLase II Dermatology Laser is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Candela GentleLase II Dermatology Laser is indicated for the following uses : 1. the photocoagulation of dermatological vascular lesions. 2. the removal of hair. The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.
Product codes
GEX
Device Description
The Candela GentleLase II Laser 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 targeted area via an optical fiber/handpiece delivery system. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLase II Laser is designed with six major components: - 1. High voltage power supply and modulator system - 2. Optical laser head - 3. Circulator system - 4. Optical delivery system - Software control system - 6. Dynamic cooling device The Candela GentleLase II Laser is 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Candela GentleLase GL laser cleared under 510(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 510(k) notification number K971737
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 4 1939
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela GentleLase II Laser System, which is substantially equivalent to previously marketed devices intended for the Photocoagulation of Dermatological vascular lesions and for the removal of hair.
| 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 Devices: | Candela GentleLase GL laser cleared under 510(k)s K981351, K972767
and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k)
K973354 and the Cynosure Apogee 40 Laser cleared under 510(k)
notification number K971737 |
Description:
The Candela GentleLase II Laser 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 targeted area via an optical fiber/handpiece delivery system. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLase II Laser is designed with six major components:
-
- High voltage power supply and modulator system
-
- Optical laser head
-
- Circulator system
-
- Optical delivery system
- న్న Software control system
-
- Dynamic cooling device
The Candela GentleLase II Laser is 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 and for hair removal.
Testing:
As a laser product, the GentleLase II is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.
Summary of Substantial Equivalence:
The Candela GentleLase II 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 devices.
On the basis of similarities in methods of assembly, method of operation, intended uses, and clinical data Candela believes that its Candela GentleLase II Laser System is substantially equivalent to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
FEB 4 1559 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Caplan Vice President Candela Laser Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K984601
Trade Name: Candela GentleLase II Dermatology Laser Regulatory Class: II Product Code: GEX Dated: December 24, 1998 Received: December 28, 1998
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 requirement, 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 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.
2
Page 2 - Mr. Jay Caplan
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 vours.
Styph Plurdic
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
510(k) Number (if known):
Device Name: Candela GentleLase II Dermatology Laser
Indications For Use:
The Candela GentleLase II Dermatology Laser is indicated for the following uses :
-
the photocoagulation of dermatological vascular lesions.
-
the removal of hair.
The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:
-
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)
Hypt Plevels
(Division Sign-Off)
Division of General Restorative Devices