(14 days)
The Cynosure Smartlipo Multiwavelength Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser is futher indicated for laser assisted lipolysis.
The Cynosure Smartlipo Multiwavelength laser is a Nd:YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
Here's an analysis of the provided information regarding the Cynosure Smartlipo Multiwavelength Laser, focusing on acceptance criteria and supporting studies:
Based on the provided K080121 510(k) summary, there are no explicit performance acceptance criteria or a study detailed that proves the device meets specific performance criteria.
The submission relies entirely on substantial equivalence to a predicate device, the Cynosure YAG Family laser. This means the FDA has determined the new device is as safe and effective as a legally marketed device, primarily because it shares the same intended use, principle of operation, and laser parameters.
Here's a breakdown of the requested information, reflecting the content of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated. The submission relies on substantial equivalence to a predicate device. | Not applicable. No specific performance metrics or data against acceptance criteria are reported. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set or clinical study data is reported.
- Data Provenance: Not applicable. No clinical data was used for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No test set requiring ground truth establishment was used.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No.
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no AI component is mentioned, and no such study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No. The device is a physical laser system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical or performance data requiring ground truth was presented. The basis for clearance is substantial equivalence to a predicate device with a history of safe and effective use.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. No training set was used, as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No training set was used.
Conclusion from the document:
The 510(k) summary explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
The conclusion for this submission is: "The Cynosure Smartlipo Mutliwavelength Laser is a safe and effective device for the 'indications for use' specified." This conclusion is drawn based on its substantial equivalence to the predicate device, the Cynosure YAG Family laser, meaning it has the same indications for use, principle of operation, and laser parameters, and therefore does not require new performance data to be demonstrated.
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| 510(K) Summary | |
|---|---|
| Submitter: | Cynosure, Inc. |
| 5 Carlisle RoadWestford, MA 01886 | |
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | January 16, 2008 |
| Device Trade Name: | Cynosure Smartlipo Multiwavelength LaserJAN 31 2008 |
| 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 Smartlipo Multiwavelength laser is a Nd:YAG laser,having a ND: YAG crystal rod as a lasing medium. It is a laser with awavelength of 1064 nm and 1320 nm. |
| Laser activation is by footswitch. Overall weight of the laser is285lbs, and the size is 41"x18"x32" (HxWxD). | |
| Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase. | |
| Intended Use: | The SmartLipo Multiwavelength Laser is intended for the surgicalincision, excision, vaporization, ablation, and coagulation of softtissue. All soft tissue is included, such as skin, cutaneous tissue,subcutaneous tissue, striated and smooth tissue, muscle, cartilagemeniscus, mucous membrane, lymph vessels and nodes, organs andglands. The SmartLipo is further indicated for laser assisted lipolysis. |
| Comparison: | The Cynosure Smartlipo Multiwavelength Laser has the equivalentindications for use, the same principle of operation, and the same laserparameters as the predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure Smartlipo Mutliwavelength Laser is a safe and effectivedevice for the 'indications for use' specified. |
| 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is presented in black and white.
Public Health Service
JAN 31 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynosure, Inc. % Mr. George Cho Senior Vice President, Medical Technology 5 Carlisle Road Westford, Massachusetts 01886
Re: K080121 Trade/Device Name: Cynosure Smartlipo Multiwavelength Laser Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 16, 2008 Received: January 17, 2008
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
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Page 2 - Mr. George Cho
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.
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 Postmarket Surveillance at (240) 276-3474. For questions regarding 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 Millman
Mark N. Melkerson 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):
Cynosure Smartlipo Multiwavelength Laser Device Name:
Indications For Use:
The Cynosure Smartlipo Multiwavelength Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser is futher indicated for laser assisted lipolysis.
Prescriptive Use X 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)
(Division Sign-Off
Division of General, Restorative, and Neurological Devices
Number L050121
§ 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.