(104 days)
Not Found
No
The summary describes a laser device with specific wavelengths and handpieces, focusing on hardware modifications and software control for energy output based on the attached handpiece. There is no mention of AI, ML, image processing, or data-driven decision-making processes.
Yes
The device is indicated for the treatment of various medical conditions, including vascular lesions, benign pigmented lesions, wrinkles, warts, scars, striae, psoriasis, and pseudofolliculitis barbae, which classifies it as a therapeutic device.
No
The document describes a laser device intended for therapeutic purposes such as hair reduction, treatment of vascular lesions, pigmented lesions, and wrinkles. It does not mention any diagnostic functions.
No
The device description clearly outlines a physical laser system with hardware components (Alexandrite crystal rod, Nd:YAG laser head, handpieces, electrical equipment) and mentions software controlling energy based on the attached handpiece, indicating it's a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for various cosmetic and therapeutic treatments performed directly on the patient's body (hair reduction, treatment of vascular lesions, pigmented lesions, wrinkles, etc.).
- Device Description: The device is a laser system designed to deliver energy to the patient's tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed for testing biological samples outside of the body. This device operates on the body.
N/A
Intended Use / Indications for Use
755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowtjng when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing medium, with a wavelength of 755 nm. The 1064 nm wavelength is generated from the Nd:YAG laser head.
Laser activation is by either by finger or foot switch. The overall weight of the laser is 180 lbs and the size is 41 x 15 x 25 in (HxWxD).
Electrical equipment is 208/240 VAC, single phase, 30A, 50/60 Hz.
The modifications to this device are four handpieces allowing for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm. The 1064 Nd:YAG laser did not require any modifications to support the new handpieces. Minor modifications, including rod diameter change and lamp fill pressure change, were made to the Alexandrite laser to increase the energy to support the larger spot sizes. The software continues to control the energy based on the handpiece attached. This prevents the increase in available energy from the laser from increasing the fluence of the existing spot sizes.
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)
Non-clinical tests submitted: Software testing confirmed that the software specifications were met.
Clinical tests submitted: None
Conclusions drawn from non-clinical data: Testing confirmed that the performance of the Elite+ Laser meets the product system requirements, which is based on the predicate device. Therefore, the modification resulted in a device that performs within the same specifications of the predicate device, and is therefore substantially equivalent.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2014
Cynosure Incorporated Ms. Kelli McMillan Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K141425 Trade/Device Name: Cynosure Elite+ Laser 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: August 11, 2014 Received: August 13, 2014
Dear Ms. McMillan:
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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141425
Device Name Cynosure Elite+ Laser
Indications for Use (Describe)
755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510k Summary Elite+ Laser Special 510(k) K141425
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (781) 993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Kelli McMillan |
| Preparation Date | September 10, 2014 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | Elite+ Laser |
| Common or Usual Name | Medical Laser System |
| Classification | II |
| Regulation Name | Laser Surgical Instrument for Use in General and Plastic Surgery |
| and in Dermatology | |
| Classification Panel | General & Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Apogee Elite K034030 | |
| 807.92(2)(4) Device Description | |
| Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing | |
| medium, with a wavelength of 755 nm. The 1064 nm wavelength | |
| is generated from the Nd:YAG laser head. | |
| Laser activation is by either by finger or foot switch. The overall | |
| weight of the laser is 180 lbs and the size is 41 x 15 x 25 in | |
| (HxWxD). | |
| Electrical equipment is 208/240 VAC, single phase, 30A, 50/60 | |
| Hz. | |
| The modifications to this device are four handpieces allowing | |
| for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm. | |
| The 1064 Nd:YAG laser did not require any modifications to | |
| support the new handpieces. Minor modifications, including | |
| rod diameter change and lamp fill pressure change, were made | |
| to the Alexandrite laser to increase the energy to support the | |
| larger spot sizes. The software continues to control the energy | |
| based on the handpiece attached. This prevents the increase in | |
| available energy from the laser from increasing the fluence of | |
| the existing spot sizes. | |
| 807/92(a)(5) Intended Use of the Device | |
| 755 nm: | |
| The Cynosure Elite+ Laser is indicated for stable long-term, or | |
| permanent hair reduction. Permanent hair reduction is defined | |
| as long-term stable reduction in the number of hairs regrowing | |
| K141425 | |
| when measured 6, 9, or 12 months after the completion of a | |
| treatment regime. It is used for all skin types (Fitzpatrick I-VI) | |
| including tanned skin. It is also indicated for the treatment of | |
| vascular lesions, benign pigmented lesions, and wrinkles. | |
| 1064 nm: | |
| The Cynosure Elite+ Laser is intended for the coagulation and | |
| hemostasis of benign vascular lesions such as, but not limited to, | |
| port wine stains, hemangiomas, warts, telangectasia, rosacea, | |
| venus lake, leg veins, spider veins and poikiloderma of civatte; | |
| and treatment of benign cutaneous lesions such as warts, scars, | |
| striae and psoriasis. The laser is also intended for the treatment | |
| of 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, | |
| keratosis and plaques. | |
| The laser is also indicated for the treatment of wrinkles such as, | |
| but not limited to, periocular and perioral wrinkles. Additionally, | |
| the laser is indicated for the treatment of pseudofolliculitis | |
| barbae (PFB) and for stable long-term, or permanent hair | |
| reduction. Permanent hair reduction is defined as 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. |
4
510k Summary Elite+ Laser Special 510(k)
5
510k Summary Elite+ Laser Special 510(k) K141425
| 807.92(a)(6) Summary of the Technological Characteristics of the Device compared to the Predicate | |||||
|---|---|---|---|---|---|
| Elite+ | |||||
| K141425 | Apogee Elite | ||||
| K034030 | |||||
| Laser Type | Alexandrite and Nd:YAG Lasers | Alexandrite and Nd:YAG Lasers | |||
| Wavelength | 755 nm | 1064 nm | 755 nm | 1064 nm | |
| Maximum Fluence | 60 J/cm | 300 J/cm | 60 J/cm | 300 J/cm | |
| Repetition Rate | 1 to 5 Hz | 1 to 10 Hz | 1 to 5 Hz | 1 to 10 Hz | |
| Pulse Duration | 0.1-300 ms | 0.1-300 ms | |||
| Spot Sizes (mm) | 3, 5, 7, 10, 12, 15, 18, 20, 22, 24 | 3, 5, 7, 10, 12.5, 15 | |||
| 807.92(b)(1) Non-clinical tests submitted | |||||
| Test | Result | ||||
| Software | The testing confirmed that the software specifications were met. | ||||
| 807.92(b)(2) Clinical tests submitted | |||||
| None | |||||
| 807.92(b)(3) Conclusions drawn from non-clinical data | |||||
| Testing confirmed that the performance of the Elite+ Laser meets the product system requirements, which is based on the predicate device. | |||||
| Therefore, the modification resulted in a device that performs within the same specifications of the predicate device, and is therefore |
substantially equivalent.