(30 days)
Not Found
No
The provided text describes a laser system for various dermatological treatments. It details the laser technology, wavelength, pulse duration control, and components. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for treatment of various medical conditions such as port wine stains, hemangioma, warts, telangiectasia, rosacea, Venus lake, leg veins, spider veins, hypertrophic and keloid scars, which are therapeutic uses.
No
Explanation: The provided text describes the Candela GentleYAG Family of Laser Systems for various cosmetic and medical treatments like hair removal, treatment of pigmented and vascular lesions, wrinkle treatment, and scar reduction. Its function is to treat conditions by delivering laser energy, not to diagnose them.
No
The device description explicitly lists hardware components such as a laser system console, control and display panel, optical fiber handpiece, footswitch/handswitch, remote interlock connector, and an optional cooling device. While it mentions software as part of the console, it is clearly a hardware-based 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that this device is a laser system used for various treatments applied directly to the body. These treatments include hair removal, treatment of pigmented and vascular lesions, soft tissue coagulation, and wrinkle treatment.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from a patient. Its function is to deliver laser energy to the skin and underlying tissues.
Therefore, the Candela GentleYAG Family of Laser Systems, as described, is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GentleYAG Family of Laser Systems is intended for:
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, 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), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, 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 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 GentleYAG Family of Laser Systems is a flashlamp-excited, Nd: YAG(Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy at a nominal wavelength of 1064 nanometers (nm) is used. This wavelength causes maximum energy absorption by the target (hair or lesion) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
The GentleYAG consists of the following main components: a laser system console (including software and control electronics) a control and display panel a lens-coupled, user replacement optical fiber handpiece with aiming beam a footswitch or handswitch a remote interlock connector an optional cooling device
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.
K010104, K0022923, K022951, K023193, K020021, K003765, K003147, K023954, K010834, K003765
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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K033172 1 of 3
Image /page/0/Picture/1 description: The image shows the Candela company logo, which is a stylized letter C. The text "CANDELA" is printed to the right of the logo. The date "OCT 3 0 2003" is printed above the text "510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS".
This 510(k) Summary of Safety and Effectiveness for the Candela GentleYAG Family of Laser Systems is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510(k) summary.
| I. General Information
| Applicant: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post Road |
| Wayland, MA 01778-1886 | |
| Contact Person: | Lorraine Calzetta Patrovic |
| Manager, Regulatory Affairs | |
| Date Prepared: | August , 2003 |
| II. Names | |
| Device Trade Name: | GentleYAG Family of Laser Systems |
| Common Name | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical |
| Instrument for use in General and Plastic | |
| Surgery and in Dermatology) |
III. Predicate Devices
Candela GentleYAG a.k.a Long Pulse Nd:YAG Laser (K010104, K0022923. K022951, K023193), Lyra I (K020021,K003765, K003147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765)
IV. Product Description
The Candela GentleYAG Family of Laser Systems is a flashlamp-excited, Nd: YAG(Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy at a nominal wavelength of 1064 nanometers (nm) is used. This wavelength causes maximum energy absorption by the target (hair or lesion) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
The GentleYAG consists of the following main components: a laser system console (including software and control electronics) a control and display panel a lens-coupled, user replacement optical fiber handpiece with aiming beam a footswitch or handswitch a remote interlock connector an optional cooling device
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K033172 2 of 3
V. Indications for Use
The GentleYAG Family of Laser Systems is intended for:
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, 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), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, 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 reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles
VI. Rationale for Substantial Equivalence
The Candela GentleYAG Family of Laser Systems shares the same indications for use, operating principles, mechanism of action, technological features as the predicate devices and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The Candela GentleYAG Laser Family of Laser Systems is equivalent to the Candela GentleYAG (aka Candela Long Pulse Nd: YAG Laser) cleared under K010104, K022923,K022951,K023193 the Lyra I ( K020021,K003765, K003147) and the Altus CoolGlide Family of Lasers (K023954, K010834,K003765) in technological features, and equivalent in intended use and therefore the risks and benefits are comparable to the predicate devices. Candela Certifies that this device is in compliance with the laser performance standards required as per 21 CFR 1000.1040. The device conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Gentle Y AG Family of Laser Systems.
VIII. Conclusion
It is the opinion of Candela Corporation that the GentleYAG Family of Laser Systems is substantially equivalent to the predicate devices based on operating principles mechanism of action, and for intended use.
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K03 3172 3 of
Statement of Substantial Equivalence
The purpose of this 510(k) submission is to obtain clearance to market the Candela Gentle YAG Family of Laser Systems.
The Candela GentleYAG Family of Laser Systems presented in this submission, is a modification of the Candela GentleY AG Laser System a.k.a Candela Long Pulse Nd: YAG previously cleared under K010104, K022951, K022923, K023193.
The modifications incorporate features of the currently marketed predicate devices, including expanded pulse durations, pulse frequencies, spot sizes, energy and indications for use. The Table of Comparative Features (included as Exhibit D) shows the features of the devices, including their similarities.
As indicated in the table, the GentleYAG Famly of Laser Systems is equivalent to the currently marketed predicate devices, the Laserscope Lyra I Nd: Y AG Laser (cleared under K020021, K0037565, K 0031747), and the Altus Cool Glide Family of Lasers (cleared under K023954, K010834, K003765), based on operating principles, mechanism of action, and shares similar functional features such as wavelength, pulse duration, pulse frequency, energy, spot sizes, and indications for use. Therefore, we do not believe that introduction of the modified GentleY AG Family of Laser Systems raises any new issues of safety or effectiveness.
In conclusion, Candela believes that the Gentle YAG family of Laser Systems is substantially equivalent to the currently marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Ms. Lorraine Calzetta Patrovic Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778-1886
Re: K033172
Trade/Device Name: Candela GentleYAG 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: II Product Code: GEX Dated: September 26, 2003 Received: September 30, 2003
Dear Ms. Patrovic:
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 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.
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Page 2 - Ms. Lorraine Calzetta Patrovic
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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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Image /page/5/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black and white, and the word "CANDELA" is in a simple, sans-serif font.
INDICATIONS FOR USE STATEMENT 033172 510(k) Number :
Candela GentleYAG Family of Laser Systems Device Name:
Indications For Use:
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, 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), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, 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 reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
Division of General, Restorative and Neurological Devices
KO33172 510(k) Number Prescription Use Over-The-Counter Use OK (Per 21 CFR 801.109)
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