(63 days)
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles, vascular lesions and inflammatory acne vulgaris.
The PhotoGenica VL is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed laser with a wavelength of 580 to 590nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The provided document is a 510(k) summary for the Cynosure PhotoGenica VL laser, which establishes substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data. Therefore, many of the requested categories related to a clinical study demonstrating acceptance criteria cannot be extracted from this document.
Here's the information that can be extracted, along with explanations for the missing categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (Nlite Laser by ICN, and Cynosure PhotoGenica VL itself as a predicate). It does not contain information about specific performance acceptance criteria for a new clinical study. The device is deemed "safe and effective" based on its equivalence to existing devices with the same indications for use, principle of operation, wavelength, and pulse energy range.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable (no clinical performance data or test set reported).
- Data Provenance: Not applicable.
Explanation: The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that no new clinical study was conducted for this submission to establish a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
Explanation: As no clinical performance data or test set was generated, there was no need for experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
Explanation: No clinical performance data or test set was generated.
5. 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
- MRMC Study: No.
- Effect Size: Not applicable.
Explanation: This device is a medical laser system, not an AI-assisted diagnostic device that would typically involve human readers. The submission explicitly states "Clinical Performance Data: none."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No.
Explanation: This is a physical medical device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable.
Explanation: No clinical performance data was generated for a new study requiring ground truth establishment. The substantial equivalence relies on the established safety and efficacy of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable.
Explanation: This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
Explanation: This is a physical medical device.
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K032565 1 of 1
510(k) SUMMARY
OCT 2 2 2003
| Submitter: | Cynsoure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | August 19, 2003 |
| Device Trade Name: | PhotoGenica VL |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.4810 |
| Equivalent Device: | Nlite Laser by ICN, and Cynosure PhotoGenica VL |
| Device Description: | The PhotoGenica VL is a pulse-dye laser, having theorganic dye as the lasing medium. It is a pulsed laserwith a wavelength of 580 to 590nm. |
| Laser activation is both by finger switch and footswitch.Overall weight of the laser is 285lbs, and the size is44"x19"x24" (HxWxD). | |
| Electrical requirement is 110 VAC or 220 VAC, 20A,50-60 Hz, single phase. | |
| Intended Use: | The PhotoGenica VL is indicated for treatment ofperiocular wrinkles, vascular lesions and inflammatoryacne. |
| Comparison: | The PhotoGenica VL laser has an equivalent indicationfor uses, the same principle of operation, the samewavelength and pulse energy range as the predicatedevices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica VL Laser is another safe and effectivedevice for dermatologic applications. |
| Additional Information: | none |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human figures connected at the shoulders, forming a wave-like shape. The figures are positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford. Massachusetts 01824
Re: K032565 Trade/Device Name: PhotoGenica VL 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: August 19, 2003 Received: August 21, 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. 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 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 vours.
Mark N Milkenm
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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501(k) Number (if known):
Device Name:
Cynosure PhotoGenica VL
Indications For Use:
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles, vascular lesions and inflammatory acne vulgaris.
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
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.