K Number
K973498
Device Name
CYNOSURE PHOTOGENICA ER LASER
Manufacturer
Date Cleared
1997-11-13

(59 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.
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.
More Information

K/DEN number: Not Found

Not Found

No
The summary describes a laser device for tissue ablation and resurfacing, with no mention of AI, ML, image processing, or data-driven decision-making.

Yes
The device is used for medical procedures like incision, excision, ablation, or vaporization of tissues, which are therapeutic actions.

No

The device is described as a laser used for surgical procedures like incision, excision, ablation, or vaporization of soft bodily tissues. There is no mention of it diagnosing conditions or providing information for diagnosis.

No

The device description clearly outlines hardware components: power supply, water cooling system, and optical bench, indicating it is a physical laser system, not software only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is used for "skin resurfacing and for 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.
  • Device Description: The description details a laser system used for surgical procedures.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laser device performs therapeutic and surgical actions directly on the patient.

N/A

Intended Use / Indications for Use

The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.

Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.

Product codes

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

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

Nonclinical Performance Data: none
Clinical Performance Data: none

Key Metrics

Not Found

Predicate Device(s)

Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

קמותחתרית החוקרים הרב

K97349P

| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 13 1997 |
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | September 11, 1997 |
| 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 and for the incision, excision, ablation or
vaporization of soft bodily tissues |
| 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 is another safe and effective laser for skin
resurfacing and for the incision, excision, ablation or vaporization
of soft bodily tissues. |
| Additional Information: | None requested at this time |

1

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

NOV 1 3 1997

Re: K973498 Trade Name: CYNOSURE PhotoGenica ER Laser Regulatory Class: II Product Code: GEX Dated: September 12, 1997 Received: September 15, 1997

Dear Mr. Cho:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

2

Page 2 - Mr. George Cho

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

toscella

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

510(k) Number (if known):_K973498

Device Name: __ Cynosure PhotoGenica Er Laser___

Indications lior Usc:

The PhotoGenica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.

Typical applications include dermatology, plastic surgery, urology, gastrocnterology, neurosurgery, gynecology, arthroscopy, general surgery. ENT and ophthalmology.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) NumberK973418

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OK

Over-The-Counter Usc__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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