(55 days)
1064nm: The Cynosure YAG MIR Family 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, venous lakes, scars, striae and poikiloderma of civatte; and treatment of telangiectasia, rosacea, venous lakes, 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, verrucea, skin tags, keratoses, tattoos (for removal 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 reduction of hair, for the treatment of melanin in the hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
1440mm: The Cynosure YAG MIR Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periocular and perioral wrinkles and pigmented lesions.
The Cynosure YAG MIR Family laser is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
This submission is for a medical laser system, a device that typically does not involve algorithms or AI. Therefore, most of the questions regarding acceptance criteria, study details, and AI performance metrics are not applicable.
Here's the information extracted from the provided text, primarily based on the 510(k) summary (section {0}) and the FDA letter {1-3}.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submitted 510(k) summary. For medical devices like lasers, acceptance criteria would typically involve performance specifications for energy output, wavelength, pulse duration, spot size, safety features, and possibly clinical efficacy endpoints. Since the submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none", there are no reported device performance metrics against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set was used as no clinical or non-clinical performance data was submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No test set and no ground truth establishment were mentioned for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. No clinical studies, including MRMC studies, were reported or performed for this 510(k) clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a laser system and does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
Not applicable. No ground truth was established as no performance data was provided.
8. The Sample Size for the Training Set
Not applicable. This device is a laser system and does not involve an AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a laser system and does not involve an AI model requiring a training set or its associated ground truth.
Summary of the 510(k) Submission:
The Cynosure YAG MIR Family Laser is a predicate device clearance. The FDA's decision to clear the device is based on its substantial equivalence to already legally marketed predicate devices. This means that the FDA determined the device has the same intended use, same principle of operation, and similar technological characteristics (wavelengths, pulse energy range) to devices already on the market.
Crucially, for this specific 510(k) submission, no new clinical or non-clinical performance data was required or submitted to demonstrate safety and effectiveness. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device(s). Therefore, the detailed questions about acceptance criteria, performance studies, and ground truth establishment, which are common for submissions involving novel technologies or performance claims, are not applicable in this case.
{0}------------------------------------------------
にER) 2006
K 053421
510(K) Summary
| Submitter: | Cynosure, Inc.5 Carlisle RoadWestford, MA 01886 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | December 7, 2005 |
| Device Trade Name: | Cynosure YAG MIR Family Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.4810 |
| Equivalent Device: | The Cynosure YAG Family laser |
| Device Description: | The Cynosure YAG MIR Family laser is a Nd:YAG laser, having aND:YAG crystal rod as a lasing medium.Laser activation is by footswitch or finger switch. Overall weight ofthe laser is 285lbs, and the size is 41"x18"x32" (HxWxD).Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. |
| Intended Use: | The Cynosure YAG MIR Family Laser is indicated for permanent hairreduction and the treatment of vascular and pigmented lesions andwrinkles. |
| Comparison: | The Cynosure YAG MIR Family Laser has the same indications foruse, the same principle of operation, and similar wavelengths andpulse energy range as the predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure YAG MIR Family Laser is a safe and effective devicefor the indications specified. |
| Additional Information: | none |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2006
Mr. George Cho Senior Vice President Medical Technology Cynosure, Inc. 5 Carlisle Road Westford, Massachusetts 01886
Re: K053421 K053421
Trade/Device Name: Cynosure YAG MIR Family Laser Frade/Dovider: 21 CFR 878.4810 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 7, 2005 Received: December 9, 2005
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device
s and the many of the county of the device is substantially equivalent (for the ind We have reviewed your Section > I'v(x) premium in the minutent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legily manced te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the organison of the Federal Food. commerce prior to May 28, 1976, the enactively with the provisions of the Federal Food. Drug,
devices that have been reclassified in accordance with the provisions of the Fed devices that have been reclassified in accordance while in the proval application (PMA).
and Cosmetic Act (Act) that do not require approval control enonvisions of the Act. and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general constructions of the Act. You may, therefore, market the uevice, subject to the genting for annual registration, listing of
general controls provisions of the Act include requirements mishranding and general controls provisions of the Act mende requirements of the security misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see a000) into chief regulations affecting your device
it may be subject to such additional controls. Existing major regulations FDA it may be subject to such additions. Extrails includes of the 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Angel can be found in the Code of Federal Regalations, The Bedgral Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s Issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device also accepcies . You must that FDA has made a determination mat your de ros seem agencies. You must or any Federal statutes and regulations administration of the tregistration and listing (21
comply with all the Act's requirements, including, but not to regurements as set comply with all the Act s requirements, mendams, out manufacturing practice requirements as school CFR Part 807); labeling (21 CFR Part 801); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1960 forin in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
{2}------------------------------------------------
Page 2 -- Mr. 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known): _
Device Name: _ Cynosure YAG MIR Family Laser
Indications For Use:
1064nm: The Cynosure YAG MIR Family laser is intended for the coagulation and hemostasis of 1004mm. The Cynosure 1710 mitted to, port wine stains, hemangiomas, warts, belligh vascular icsions, such as , out hovement and poikiloderma of civatte; and treatment of telangicolasia, rosacca, vehas sates, scars, stiae 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, verrucea, skin tags, keratoses, tattoos spors), Caro an fair masures, 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 Adultionally, the laser is marbated for attreating of melanin in the hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
1440mm: The Cynosure YAG MIR Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also ior the meision, oneible, actuacia, winkles and perioral wrinkles and pigmented lesions.
Over-The-Counter Use X OR Prescriptive Use (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carlene Beecher Der MKM
Division of General. Restorative, and Neurological Desires
510(k) Number_ (05 542 _
§ 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.