(88 days)
Not Found
Not Found
No
The summary describes a laser device with standard components and parameters, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as being used for "skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues," which directly addresses a medical condition or modifies bodily function.
No
The device description states its use is for "skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues," which describes a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components (power supply, water cooling system, optical bench) and describes a physical laser, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for skin resurfacing and the incision, excision, ablation, or vaporization of soft bodily tissues. These are all procedures performed on the body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a laser system used for delivering energy to tissue. This is consistent with a therapeutic or surgical device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This laser device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft bodily tissues, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(K) Summary
NOV 1 6 2001
k 012790
ﺴﺴﺴﺴﺴﺴﺴﺴ
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior 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, laser
79-GEX
21 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. At
20 pulses per second and a pulse energy of 2 Joules, the average power
from the laser is 20 watts. |
| Intended Use: | Skin resurfacing in the treatment of wrinkles. |
| Comparison: | 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. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The PhotoGenica ER Laser is another safe and effective way to
remove or reduce wrinkles, and to ablate or excise tissue. |
| Additional Information: | None requested at this time |
1
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.
2
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
Image /page/2/Picture/5 description: The image shows a close-up of a handwritten letter 'fa' in cursive. The letters are connected, with the 'f' extending upwards and looping over, and the 'a' following closely behind. The writing appears to be done with a pen or marker, and the ink is dark.
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
3
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)