(82 days)
Not Found
No
The device description details a laser system with user-selectable parameters controlled by a microprocessor. There is no mention of AI, ML, or any learning algorithms used for decision-making or parameter adjustment.
Yes
The device is indicated for the treatment of various medical conditions such as pigmented lesions, vascular lesions, and scars, which falls under the definition of a therapeutic device.
No
The device is indicated for various cosmetic and therapeutic treatments like hair reduction, treatment of pigmented and vascular lesions, and wrinkle reduction, but not for diagnosing medical conditions.
No
The device description clearly outlines significant hardware components including laser heads, flashlamps, power supply, optical fiber, and a handpiece, indicating it is a hardware-based medical device with software control.
Based on the provided information, the Candela 3630 Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to therapeutic and cosmetic treatments performed directly on the patient's body. These include hair reduction, treatment of pigmented lesions, wrinkles, vascular lesions, and tattoos. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a laser system designed to deliver energy to the patient's skin. It describes components like laser heads, flashlamps, optical fibers, and handpieces, all consistent with a device used for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Candela 3630 Laser System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
755mm
The Candela 3630 Laser System is indicated for the 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. On all skin types (Fitzpatrick I-IV) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
1064nm
The Candela 3630 Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tarned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Bening pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheio keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tuttoos (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 lessons 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 reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela 3630 Laser System contains two separate laser heads (Alexandrite and Nd Y AG) which produce laser light outputs of 755 mm and 1064 nm. The outputs of each laser head are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 mm, 1064 nm wavelengths.
Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature. A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.
The Candela 3630 Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds (See attached specification 9914-92-0400 for further details). The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fillerice) level and reportion rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration fantal and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela 3630 Laser System supports spot sizes from 1.5 to 18 mm.
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)
Not Found
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.
K033172, K024371, K024335, K024260, K034030
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
Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame-like shape on the left, with horizontal lines suggesting heat or energy emanating from it. To the right of the flame is the word "CANDELA" in a simple, sans-serif font.
K 063074
510(k) Summary
DEC 2 7 2006
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
Submitter Information
| Company Name: | Candela Corporation |
|---|---|
| Company Address: | 530 Boston Post Road |
| Wayland, MA 01778 | |
| Company Phone: | 508-358-7400 |
| Company Facsimile: | 508-358-5602 |
| Contact Person: | Mr. Jeffrey Roberts |
| Manager, Regulatory Affairs | |
| Date summary Prepared: | 10/05/06 |
Device Identification
| Device Trade/Proprietary Name:Candela 3630 Laser System | |
|---|---|
| Common Name: | Medical Laser System |
| Classification Name: | Laser Surgical Instrument, for use in General and Plastic |
| Surgery and Dermatology | |
| Classification Regulation: | 21 CFR § 878.4810 |
| Device Classification: | II |
Identification of Predicate Device
Predicate Device(s): Candela Gentle Y AG Family of Laser Systems, K033172 Candela GentleLASE Family of Laser Systems, K024371 Candela GentleLASE Family of Laser Systems. K024335 Candela GentleLASE Family of Laser Systems, K024260 Cynosure Apogee Elite Laser, K034030
Device Description
The Candela 3630 Laser System contains two separate laser heads (Alexandrite and Nd Y AG) which produce laser light outputs of 755 mm and 1064 nm. The outputs of each laser head are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 mm, 1064 nm wavelengths.
Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a
1
controlled temperature. A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.
The Candela 3630 Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds (See attached specification 9914-92-0400 for further details). The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fillerice) level and reportion rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration fantal and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela 3630 Laser System supports spot sizes from 1.5 to 18 mm.
Description of Intended Use
755nm
The Candela 3630 Laser System is indicated for the temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follieles. Premanent 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-IV) including tanned skin.
Treatment of benign pigmented lessons. Treatment of wrinkles.
1064nm
The Candela 3630 Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted 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, hemoangioma, warts, telandievas sia, rosseea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft thesue. Bening pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tatoos (significant reduction in the intensity of black and/or blue-black tartoos) and plaques a
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 harvenot responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
2
Rationale for Substantial Equivalence
The Candela 3630 Laser System has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) . as the predicate devices.
The Candela 3630 Laser System shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the currently legally marketed Candela GentleY AG Family of Laser Systems, K033172, Candela GentleLASE Family of Laser Systems, K024371. K024335. K024260, and Cynosure Apoyee Elite Laser, K034030 predicate devices.
Safety and Effectiveness Information
The Candela 3630 Laser System is substantial equivalent to the currently legally marketed Candela Gentle YAG Family of Laser Systems, K033172, Candela GentleLASE Family of Laser Systems, K024371, K024335, K024260, and Cynosure Apogee Elite Laser, K034030 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela 3630 Laser System.
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela 3630 Laser System has been shown to be substantially equivalent to the current legally marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
DEC 2 7 2006
Re: K063074 Trade/Device Name: Candela 3630 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery
and in dermatology Regulatory Class: II Product Code: GEX Dated: October 5, 2006 Received: October 10, 2006
Dear Mr. Roberts:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Jeffrey Roberts
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Ваввие Вискио
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K063074
Device Name: Candela 3630 Laser System
Indications for Use:
755mm
The Candela 3630 Laser System is indicated for the 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. On all skin types (Fitzpatrick I-IV) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
1064nm
The Candela 3630 Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tarned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Bening pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheio keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tuttoos (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 lessons 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 reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Jarbare Bucklund
(Division Sign-Off) Division of General, Restorative,
and Ivouronoging and leveres
510(k) Number K063074
6
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Buchner
(Division Sign-Off) (Division Signeral, Restorative, Division of Neurological Devices
510(k) Number K063074