(161 days)
The Candela GentleLASE GL Dermatology Laser is indicated for the following uses :
- The Photocoagulation of Dermatological vascular lesions.
- Temporary hair reduction.
- Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. It is also intended for the photocoagulation of dermatological vascular lesions.
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 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 Lasers are designed with six major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
- Software control system
- Dynamic cooling device
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 provided text is a 510(k) Summary for the Candela GentleLASE GL Laser System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical specifications and intended uses.
Crucially, the document explicitly states: "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." However, beyond this high-level statement, the document does NOT provide detailed information about the acceptance criteria, specific performance metrics, or the study design requested in the prompt.
Therefore, I cannot extract the specific information about acceptance criteria and the study that proves the device meets them from the provided text. The document is a regulatory submission for substantial equivalence, not a detailed clinical study report.
Based on the provided text, I can only state the following:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states, "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, hair count reduction percentages, etc.) are listed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not provided in the document.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system for dermatology, not an AI-assisted diagnostic tool that would involve "human readers."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm only" component in the sense of AI diagnostics. Its performance is directly tied to the physical application of laser energy by a human operator.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but it would presumably be clinical outcomes data related to hair reduction and safety observations.
- The sample size for the training set: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.
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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 and for the permanent reduction of hair counts.
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General andPlastic Surgery and in Dermatology) |
|---|---|
| Common Name: | Dermatology Laser, Long pulse Alexandrite Laser |
| Predicate Devices: | Candela GentleLASE GL laser cleared under 510(k) 974381, cleared onFebruary 10, 1998. The hair count reduction indication as included in 510(k)K981351, was cleared on July 13, 1998. The Star Medical Technologies, Inc.LightSheer™ Laser, which was cleared for the indication of permanent hairreduction under 510(k) number K982940. The Palomar Medical Technologies,Inc. EpiLaser®, was cleared for the indication of permanent hair reductionunder 510(k) number K980517. The Laserscope Lyra™ Laser System, wascleared for treatment of vascular lesions under 510(k) number K990903. |
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 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 Lasers are designed with six major components:
- High voltage power supply and modulator system 1.
-
- Optical laser head
- Circulator system 3.
-
- Optical delivery system
- Software control system 5.
-
- Dynamic cooling device
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 uses of the laser system are for the Photocoagulation of Dermatological vascular lesions and for Temporary hair reduction. It is also intended to effect stable long-term or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
Testing:
A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues.
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 devices.
On the basis of similarities in methods of assembly, method of operation, intended uses, and clinical data Candela believes that its Candela GentleLASE Laser System is substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2000
Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
K994260 Re:
Trade Name: Candela GentleLASE GL Dermatology Laser Regulatory Class: II Product Code: GEX Dated: February 29, 2000 Received: March 1, 2000
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 Costical Fel (110). I 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 (1 remations 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 tuch 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.
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Page 2 - Mr. Jay Caplan
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to ocgan mainenses of your device 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. ad vertibing or your a regulation entitled, "Misbranding by reference to premarket Also, picase note the regulation only and information on your responsibilities under the nothloudon' (21 OF IC 0017) vision 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,
Donna R. Lochner -
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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510(k) Number (if known): K994260
Device Name: Candela (Modified) GentleLASE GL Dermatology Laser
Indications For Use:
The Candela GentleLASE GL Dermatology Laser is indicated for the following uses :
- The Photocoagulation of Dermatological vascular lesions. 1.
- Temporary hair reduction. 2.
- Stable long-term, or permanent hair reduction through 3 . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. It is also intended 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)
Dune R. Lochner.
(Division Sign-Off) Invision Sign-O1-O1-O1-( 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)
§ 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.