(90 days)
Not Found
No
The description focuses on the physical components and basic software control of a laser system, with no mention of AI or ML capabilities.
Yes
The device is used for the photocoagulation of dermatological vascular lesions and hair removal, which are therapeutic medical procedures.
No
The device is indicated for photocoagulation and hair removal, which are treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
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 about a person's health. This testing is done outside of the body ("in vitro").
- Candela GentleLase GL Function: The description clearly states that the Candela GentleLase GL Laser is used for direct treatment on the body: photocoagulation of dermatological vascular lesions and hair removal. It applies energy to the body, not to a specimen from the body.
The device description and intended uses are consistent with a therapeutic or surgical laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal.
The Candela GentleLase GL Dermatology Laser is indicated for the following uses:
- the Photocoagulation of Dermatological vascular lesions.
- the removal of hair.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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)
A clinical trial demonstrated that the GentleLase Laser System removes unwanted hair without raising any unexpected safety issues.
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 laser cleared under 510(k) 974381, Cynosure Photogenica LP Laser cleared under 510(k) notification numbers K963094 and K971737, Sharplan Model 5000 Laser cleared under 510(k) number 971784
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
981j3)7
JUL 13 1998
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 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) 974381, Cynosure
Photogenica LP Laser cleared under 510(k) notification numbers K963094
and K971737 and the Sharplan Model 5000 Laser cleared under 510(k)
number 971784 | |
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
- Optical laser head 2.
-
- Circulator system
- Optical delivery system 4.
- న్న 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 intended use of the laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal.
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.
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, composed of three overlapping profiles facing to the right. The profiles are rendered in black and have a flowing, wave-like quality. 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
JUL 1 3 1998
Mr. Jay Caplan ·Vice President Candela Laser Corporation 530 Boston Post Road Wayland. Massachusetts 01778-1886
Re: K981351 Trade Name: Candela GentleLase GL Dermatological Laser Regulatory Class: II Product Code: GEX Dated: April 13, 1998 Received: April 14, 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 (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 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.
2
Page 2 - Mr. Jay Caplan
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,
Callie M. Witte, PhD, MD
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
g81351
510(k) Number (if known):
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 1. lesions.
- the removal of hair. 2.
(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 | K981351 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| -------------------------------------------------------- | ---- | ---------------------- |
(Optional format 1-2-96)(