(88 days)
The PhotoGenica ER laser is used for skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues.
The PhotoGenica ER Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 20 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 20 watts.
The provided FDA 510(k) summary for the Cynosure PhotoGenica ER Laser states "Clinical Performance Data: none" and "Nonclinical Performance Data: none". This indicates that the submission did not include specific acceptance criteria or a study demonstrating the device meets such criteria in the traditional sense of a clinical trial or performance study with quantified metrics.
Instead, the FDA determined substantial equivalence primarily based on the device's technical characteristics being comparable to a legally marketed predicate device (Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser) and the intended use. The 510(k) process for this type of device focuses on demonstrating that the new device is as safe and effective as a predicate device, often without requiring new clinical data if technological characteristics are sufficiently similar.
Therefore, the requested information cannot be fully provided as it pertains to a type of performance study that was not part of this 510(k) submission. However, I can infer what the "acceptance criteria" for the 510(k) itself were, which primarily revolved around demonstrating substantial equivalence.
Here's an attempt to answer based on the provided document, acknowledging the lack of a clinical performance study:
1. A table of acceptance criteria and the reported device performance
Since no clinical or nonclinical performance data was provided or required for this 510(k) submission, there are no explicit acceptance criteria for a performance study. The "acceptance criteria" for the 510(k) process in this case were met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Inferred for 510(k) Submission) | Reported Device Performance (Inferred for 510(k) Submission) |
|---|---|
| Criterion: Device is substantially equivalent to a legally marketed predicate device in terms of intended use and technological characteristics. | Performance: "The PhotoGenica ER Laser is substantially equivalent to the Continuum Biomedical CB Erbium / 2.94™ Er: YAG Laser in terms of treatment wavelength, pulse duration, pulse energy, and biological effects." |
| Criterion: Intended use is consistent with the predicate device. | Performance: Intended for "Skin resurfacing in the treatment of wrinkles" and "incision, excision, ablation or vaporization of soft bodily tissues," similar to the predicate. |
| Criterion: Device is safe and effective for its intended use. | Performance: "The PhotoGenica ER Laser is another safe and effective way to remove or reduce wrinkles, and to ablate or excise tissue." (Conclusion reached by the submitter and accepted by FDA through substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical or nonclinical test set was used for performance evaluation as part of this 510(k) submission.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established as no clinical or nonclinical performance study was conducted.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This device is a laser system, not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was used for a performance study. The ground for substantial equivalence was based on comparison to an existing, legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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510(K) Summary
NOV 1 6 2001
k 012790
ﺴﺴﺴﺴﺴﺴﺴﺴ
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | August 16, 2001 |
| Device Trade Name: | PhotoGenica ER Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser |
| Device Description: | The PhotoGenica ER Laser consists of three interconnected sections:the power supply, the water cooling system and the optical bench. At20 pulses per second and a pulse energy of 2 Joules, the average powerfrom the laser is 20 watts. |
| Intended Use: | Skin resurfacing in the treatment of wrinkles. |
| Comparison: | The PhotoGenica ER Laser is substantially equivalent to theContinuum Biomedical CB Erbium / 2.94™ Er: YAG Laser in terms oftreatment wavelength, pulse duration, pulse energy, and biologicaleffects. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica ER Laser is another safe and effective way toremove or reduce wrinkles, and to ablate or excise tissue. |
| Additional Information: | None requested at this time |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an emblem that resembles an eagle with three stripes above its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K012790
Trade/Device Name: PhotoGenica ER Laser Regulation Number: 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 16, 2001 Received: August 20, 2001
NOV 1 6 2001
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) I mis letter will and in yourse finding of substantial equivalence of your device to a legally promance holized 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration entitives, which on your responsibilities under the Act may be obtained from the Oixision 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,
Susan Walker, MD
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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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NOV 1 6 2001
Page Page of
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _ Cynosure PhotoGenica ER Laser
Indications For Use:
The PhotoGenica ER laser is used for skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walk, 17
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use
✓
510(k) Number 12012790
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.