(43 days)
Not Found
No
The document describes a laser and pulsed light system for various dermatological treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The predicate devices are also laser/light systems without apparent AI/ML components.
Yes
The device is indicated for treatment of various medical conditions such as vascular lesions, pigmented lesions, warts, scars, striae, psoriasis, pseudofolliculitis, and acne, which are therapeutic uses.
No
This device is described as a laser system intended for various treatments (hair reduction, vascular lesions, pigmented lesions, wrinkles, etc.), not for diagnosing conditions.
No
The device is described as a "solid state laser system" that emits laser energy and incorporates a "pulsed light XPL handpiece." This clearly indicates it is a hardware-based medical device, not software-only.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Cynosure Elite MPX Laser System clearly indicate it is a therapeutic device that uses laser and pulsed light energy to treat various conditions directly on the patient's body (hair reduction, vascular lesions, pigmented lesions, wrinkles, acne). It does not involve the analysis of specimens taken from the body.
Therefore, the Cynosure Elite MPX Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The current 510(k) is for the Cynosure Elite MPX Laser System with XPL Handpiece.
Elite MPX 755 nm:
The Elite MPX Laser system is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Elite MPX 1064 nm:
The Elite MPX laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, 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), café au lait macules, seborrheic keratoses, nevi, chloasma, verruca, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) 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 removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliclitis (PFB).
XPL Handpiece:
The XPL Pulsed Light handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cynosure Elite MPX Laser System with XPL Handpiece is a solid state laser system. It emits laser energy at 755nm and 1064nm wavelengths. It also incorporates a pulsed light XPL handpiece.
Laser activation is by footswitch.
Electrical requirement is 230 VAC, 30A, 50-60 Hz, single phase.
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)
Nonclinical none Performance Data:
Clinical Performance none Data:
The Elite MPX Laser System with XPL Handpiece is a safe and effective device Conclusion: for the indications specified.
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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mar 1 7 2009
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| Submitter: | 510(K) Summary
Cynosure, Inc., 5 Carlisle Road, Westford, MA 01886 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho, Senior Vice President of Medical Technology |
| Date Summary
Prepared: | January 30, 2009 |
| Device Trade Name: | Cynosure Elite MPX Laser System with XPL Handpiece |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device: | Cynosure Apogee Elite (K034030) and Cynosure PhotoSilk Plus Pulsed Light
System (K051442) |
| Device Description: | The Cynosure Elite MPX Laser System with XPL Handpiece is a solid state laser
system. It emits laser energy at 755nm and 1064nm wavelengths. It also
incorporates a pulsed light XPL handpiece. |
| | Laser activation is by footswitch. |
| | Electrical requirement is 230 VAC, 30A, 50-60 Hz, single phase. |
| Intended Use: | Elite MPX 755 nm:
The Elite MPX Laser system is indicated for stable long-term, or permanent hair reduction.
Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth
after a treatment regime. It is used for all skin types (Fitzpatrick I - IV) including tanned skin. It
is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Elite MPX 1064 nm: |
| | The Elite MPX laser system is intended for the coagulation and hemostasis of benign vascular
lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea,
venus lakes, 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), café au lait macules, seborrheic keratoses, nevi, chloasma, verruca, skin tags,
keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) 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 removal of unwanted hair, for the stable long-term, or
permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the
treatment of pseudofolliclitis (PFB). |
| | XPL Handpiece: |
| | The XPL Pulsed Light handpiece is intended for permanent hair reduction and the treatment of
dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory
acne. |
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1
The Cynosure Elite MPX Laser System with XPL Handpiec has the same Comparison: indications for use, the same principle of operation, and same parameters as the predicate device(s). Nonclinical none Performance Data: Clinical Performance none Data: The Elite MPX Laser System with XPL Handpiece is a safe and effective device Conclusion: for the indications specified. Additional none
Information:
:
2
Image /page/2/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" around the perimeter. Inside the circle is an abstract image of an eagle.
MAR 1 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynosure, Inc. % Mr. George Cho Sr. Vice President 5 Carlisle Road Westford, Massachusetts 01886
Re: K090235
Trade/Device Name: cynosure Eite MPX Laser System with XPL Handpiece 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: January 30, 2009 Received: February 2, 2009
Dear Mr. Cho:
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.
3
Page 2 - Mr. George Cho
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ KO90235
Device Name: Cynosure Elite MPX Laser System with XPL Handpiece
Indications For Use:
Elite MPX 755 nm:
The Elite MPX Laser system is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - IV) including tanned skin. It is also indicated for the treatment of vascular lesions, and wrinkles.
Elite MPX 1064 nm:
The Elite MPX laser system is intended for the coagulation and hemostasis of benign vascular lessons such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins, and poiklioderma of civate; and treatment of benign cutaneous lesions such as warts, scars, striae and psociasis. The laser is also intended for the treatment of beniented lesions such as , but not limited to lentinos (age spots), solar lentigos (sun spots), cafe an lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) 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 removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliclitis (PFB).
XPL Handpiece:
The XPL Pulsed Light handpiece is intended for permanent hair reatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
Prescriptive Use OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Nilk R. Oblea for mxn
Division of General, Restorative, and Neurological Devices
510(k) Number K090235