(228 days)
Not Found
No
The summary describes a laser system for dermatological treatments and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for medical treatments such as temporary hair reduction, treatment of benign pigmented lesions, treatment of wrinkles, and photocoagulation of dermatological vascular lesions, which are therapeutic procedures.
No
This device is a therapeutic laser system used for hair reduction, treatment of benign pigmented lesions, wrinkles, and dermatological vascular lesions, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a laser head, optical fiber delivery system, and a Dynamic Cooling Device (DCD). While a software update is mentioned, the device itself is a physical 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 Description and Intended Use: The description clearly states that the GentleLASE Family of Laser Systems is a laser system that delivers energy to the skin for therapeutic purposes (hair reduction, treatment of lesions and wrinkles). It operates externally on the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the GentleLASE Family of Laser Systems falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.
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
Prescription Use
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 software update is being made to the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE) due to a recall, therefore software verification and validation have been performed. Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 has been conducted on the GentleLase Pro and GentleLase Pro LE laser systems. All performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems perform according to specifications and functions as intended.
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.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a flowing, stylized manner. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Candela Corporation Mr. Sam Wade Vice President, Regulatory Affairs and Quality Assurance 530 Boston Post Road Wayland, Massachusetts 01778
Re: K140732
Trade/Device Name: GentleLASE Family of Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 9, 2014 Received: October 10, 2014
Dear Mr. Wade:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name GentleLASE Family of Laser Systems
Indications for Use (Describe)
The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
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4
510(k) Summary GentleLASE Family of Laser Systems
General Information:
This Special 510(k) is to provide notification of a software change made for the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE Laser Systems) to the previously cleared GentleMAX Family of Laser Systems (K133283) manufactured by Candela Corporation.
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Sam Wade.
Vice President, Regulatory Affairs and Quality Assurance
Tel: 508-358-7400 x330
Fax: 508-358-5602 | |
| Date prepared: | March 14, 2014 | |
| Trade Name: | GentleLASE Family of Laser Systems | |
| Common Name: | Dermatology Laser System | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and
in dermatology (21 CFR 878.4810, Product Code GEX) | |
| Predicate Devices: | GentleMAX Family of Laser Systems (K133283) | |
Intended Use / Indications for Use:
The GentleLASE Family of Laser Systems is indicated for the following:
The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
GentleLASE Family of Laser Systems
5
Description:
The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.
| Product | Modified GentleLASE Family of
Laser Systems (GentleLase Pro
and GentleLase Pro LE Laser
Systems) | GentleMAX Family of Laser
Systems |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | KXXXXXXX | K133283 |
| Manufacturer | Candela Corporation | Candela Corporation |
| Product Code | GEX | GEX |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Device Class | II | II |
| Indications for
Use | The GentleLASE Family of Laser
Systems is indicated for temporary
hair reduction. Stable long-term or
permanent 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.
On all skin types (Fitzpatrick I- VI)
including tanned skin. Permanent
hair reduction is defined as the long-
term, stable reduction in the number
of hairs regrowing when measured at
6, 9, and 12 months after the
completion of a treatment regime.
Treatment of benign pigmented
lesions.
Treatment of wrinkles.
The photocoagulation of | 755nm
The GentleMAX Family of Laser
Systems is indicated for temporary
hair reduction. Stable long-term or
permanent 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.
On all skin types (Fitzpatrick I- VI)
including tanned skin. Permanent
hair reduction is defined as the long-
term, stable reduction in the number
of hairs regrowing when measured at
6, 9, and 12 months after the
completion of a treatment regime.
Treatment of benign pigmented
lesions.
Treatment of wrinkles.
The photocoagulation of |
| Product | Modified GentleLASE Family of | GentleMAX Family of Laser |
| | Laser Systems (GentleLase Pro | Systems |
| | and GentleLase Pro LE Laser | |
| | Systems) | |
| | dermatological vascular lesions | dermatological vascular lesions |
| | (such as port-wine stains, | (such as port-wine stains, |
| | hemangiomas, telangiectasias). | hemangiomas, telangiectasias. |
| | | |
| | | 1064nm |
| | | The GentleMAX Family of Laser |
| | | Systems is indicated for the removal |
| | | of unwanted hair, for stable long |
| | | term or permanent hair reduction |
| | | and for treatment of PFB. |
| | | Permanent hair reduction is defined |
| | | as the long-term, stable reduction in |
| | | the number of hairs regrowing when |
| | | measured at 6, 9, and 12 months |
| | | after the completion of a treatment |
| | | regime. The lasers are indicated on |
| | | all skin types Fitzpatrick I-VI |
| | | including tanned skin. |
| | | Photocoagulation and hemostasis of |
| | | pigmented and vascular lesions such |
| | | as but not limited to port wine stains, |
| | | hemangioma, warts, telangiectasia, |
| | | rosacea, venus lake, leg veins and |
| | | spider veins. Coagulation and |
| | | hemostasis of soft tissue. Benign |
| | | pigmented lesions such as, but not |
| | | limited to, lentigos (age spots), solar |
| | | lentigos (sun spots), café au lait |
| | | macules, seborrheic keratosis, nevi, |
| | | chloasma, verrucae, skin tags, |
| | | keratosis, tattoos (significant |
| | | reduction in the intensity of black |
| | | and/or blue-black tattoos) and |
| | | plaques.
The laser is indicated for pigmented |
| | | lesions to reduce lesion size, for |
| | | patients with lesions that would |
| | | potentially benefit from aggressive |
| | | treatment, and for patients with |
| | | lesions that have not responded to |
| | | other laser treatments. |
| | | The laser is also indicated for the |
| | | |
| Product | Modified GentleLASE Family of
Laser Systems (GentleLase Pro
and GentleLase Pro LE Laser
Systems) | GentleMAX Family of Laser
Systems |
| | | reduction of red pigmentation in
hypertrophic and keloid scars where
vascularity is an integral part of the
scar.
Treatment of wrinkles. |
| Laser type | Flashlamp-excited, Solid state
Alexandrite laser | Flashlamp-excited, Solid state
Alexandrite and Nd:YAG laser |
| Wavelength | 755nm | 755nm/1064nm |
| Pulse duration | 3 – 300 ms | 0.25 - 100 ms |
| Maximum
fluence | $53 J/cm²$ | $53 J/cm²$ (ALEX)
$80 J/cm²$ (YAG) |
| Spot size | 6, 8, 10, 12, 15, 18, 20, 22, 24mm | 1.5, 3, 6, 8, 10, 12, 15, 18mm |
| Pulse repetition
rate | 2 Hz, maximum | 10 Hz, maximum |
| Pulsing control | Fingerswitch or footswitch | Fingerswitch or footswitch |
| Laser Cooling
Method | Self-contained internally circulated
liquid to air | Self-contained internally circulated
liquid to air |
| Product
dimensions
(HxWxL) | 42" x 18" x 27" | 42" x 18" x 27" |
| Product
Weight | 250 lbs | 260 lbs |
Technological Characteristics:
6
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Performance Data:
A software update is being made to the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE) due to a recall, therefore software verification and validation have been performed. Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 has been conducted on the GentleLase Pro and GentleLase Pro LE laser systems. All performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems perform according to specifications and functions as intended.
Clinical Data:
No clinical data was required for these modifications.
Summary of Substantial Equivalence:
The modifications made to the GentleLASE Family of Laser Systems do not affect the indications for use or alter the fundamental scientific technology of the device, nor does it affect the mode of use. There are no labeling changes that affect the indications for use of the device. The modifications made to the GentleLASE Family of Laser Systems raises no new issues of safety or effectiveness. The modified GentleLASE Family of Laser Systems have the same intended uses, utilizes similar operating principles, and matches key design aspects, including
GentleLASE Family of Laser Systems
8
similar spot size, similar wavelength and the same maximum delivered fluence as the predicate device. The non-clinical tests that were performed that our device is as safe, as effective, and performs as well as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, as confirmed by the performance testing, Candela Corporation believes that the modified GentleLASE Family of Laser Systems is substantially equivalent to the predicate device.