(42 days)
The Cynosure Apogee Elite laser is indicated for permanent hair reduction and the treatment of vascular lesions, pigmented lesions, and wrinkles.
755 nm:
The Cynosure Apogee Elite Dermatological 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 hair regrowth after 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 Apogee Elite Dermatological laser 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 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), café' 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 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 hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
Cynosure Apogee Elite laser (755nm), having 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 finger or foot switch. Overall weight of the laser is 45 Kg, and the size is 113x53x84 cm (HxWxD). Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cynosure Apogee Elite Laser:
This 510(k) summary does not include any acceptance criteria or a study proving the device meets said criteria. Instead, it relies on substantial equivalence to predicate devices.
Let's break down the reasons and why this document doesn't fit the request:
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A table of acceptance criteria and the reported device performance:
- Not found. This document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."
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Sample size used for the test set and the data provenance:
- Not found. Since no studies were conducted or provided, there is no test set or data provenance to report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not found. No test set means no ground truth establishment by experts.
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Adjudication method for the test set:
- Not found. No test set means no adjudication method.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical laser system, not a software algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Not found. No ground truth was established as no performance data was provided for the device.
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The sample size for the training set:
- Not found. No training set was used as no new performance data was generated for this 510(k). The device is cleared based on equivalence.
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How the ground truth for the training set was established:
- Not found. No training set means no establishment of ground truth for it.
Summary of the document's approach:
The Cynosure Apogee Elite Laser's 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices (Cynosure Apogee TKS, Cynosure Acclaim). This means the manufacturer argues that their new device is as safe and effective as existing predicate devices because it shares the "same principle of operation, the same wavelength and essentially the same power range and the same indications for uses."
Therefore, this document does not contain the information requested about specific acceptance criteria or performance studies demonstrating the device meets those criteria. It is a clearance based on comparison rather than new performance data.
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FEB - 9 2004
:
FEB - 9 2004 K0340 30 1 of 1
510(K) Summary
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | December 23, 2003 |
| Device Trade Name: | Cynosure Apogee Elite Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.4810 |
| Equivalent Device: | Cynosure Apogee TKS, Cynosure Acclaim |
| Device Description: | Cynosure Apogee Elite laser (755nm), having an Alexandrite crystalrod as the lasing medium, with a wavelength of 755 nm. The 1064 nmwavelength is generated from the Nd:YAG laser head.Laser activation is by either finger or foot switch. Overall weight ofthe laser is 45 Kg, and the size is 113x53x84 cm (HxWxD).Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase. |
| Intended Use: | The Cynosure Apogee Elite laser is indicated for permanent hairreduction and the treatment of vascular lesions, pigmented lesions, andwrinkles. |
| Comparison: | The Cynosure Apogee Elite laser is substantially equivalent to thepredicate devices, with the same principle of operation, the samewavelength and essentially the same power range and the sameindications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure Apogee Elite laser is another safe and effective devicefor permanent hair reduction and treatment of vascular lesions,pigmented lesions and wrinkles |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2004
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K034030 Trade/Device Name: Cynosure Apogee 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: II Product Code: GEX Dated: December 24, 2003 Reccived: December 29, 2003
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.
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Page 2 - Mr. Goorge 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 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,
Sincerely yours,
Mark N. Mulkern
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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510(k) Number (if known):
Device Name: _ Cynosure Apogee Elite Dermatological Laser
Indications For Use:
755 nm:
The Cynosure Apogee Elite Dermatological 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 hair regrowth after 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 Apogee Elite Dermatological laser 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 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), café' 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 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 hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Over-The- Counter-Use
§ 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.