Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser device and its intended uses, focusing on the physical characteristics and applications of the laser wavelengths. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML technologies in medical devices.

Therapeutic

Yes
The device is described as treating various medical conditions, including vascular lesions, benign cutaneous lesions, pigmented lesions, wrinkles, and for hair removal and soft tissue incision/ablation, which are all therapeutic interventions.

Diagnostic

No

The device description and intended use indicate that the Cynosure YAG Family laser is used for various treatments (coagulation, hemostasis, incision, excision, ablation, vaporization, hair removal, wrinkle treatment) of lesions and tissues, rather than for identifying or diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical laser system with specific dimensions, weight, and electrical requirements, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a laser device used for various dermatological and surgical procedures performed directly on the patient's body (coagulation, hemostasis, treatment of lesions, hair removal, wrinkle treatment, incision, excision, ablation, vaporization).
Device Description: The description details a laser system with specific wavelengths and physical characteristics, consistent with a therapeutic or surgical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the human body. This device is used to directly treat the human body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cynosure YAG Family Laser is indicated for permanent hair reduction and the treatment of vascular and pigmented lesions and wrinkles.

1064 nm: The Cynosure YAG Family laser is intended for the coagulation and hemostasis of bonion vascular lesions such as, but not limited to, port winc stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, stiae and psoriasis. The laser is also intended for the treatment of bonign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café' au lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

1320 nm The Cynosure YAG Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The Cynosure YAG Family Laser is a Nd: Y AG laser, having a Nd: Y AG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm and 1,320 nm. Laser activation is by foot switch or finger switch. Overall weight of the laser is 81 Kg, and the size is 112x48x71 cm (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

K031690 1 of 1

JUL 0 8 2003

510(K) Summary

| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | May 30, 2003 |
| Device Trade Name: | Cynosure YAG Family Laser (PhotoGenical YAG and Acclaim) |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Devices: | Altus CoolGlide Family, ICN CoolTouch / CoolTouch II, Sciton
Profile 1320 |
| Device Description: | The Cynosure YAG Family Laser is a Nd: Y AG laser, having a
Nd: Y AG crystal rod as the lasing medium. It is a laser with a
wavelength of 1,064 nm and 1,320 nm. |
| | Laser activation is by foot switch or finger switch. Overall weight of
the laser is 81 Kg, and the size is 112x48x71 cm (HxWxD). |
| | Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase. |
| Intended Use: | The Cynosure YAG Family Laser is indicated for permanent hair
reduction and the treatment of vascular and pigmented lesions and
wrinkles. |
| Comparison: | The Cynosure YAG Family Laser has an equivalent indication for
uses, the same principle of operation, the same wavelengths and
essentially the same pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure YAG Family Laser is another safe and effective device
for permanent hair reduction and treatment of pigmented lesions and
wrinkles. |
| Additional Information: | none |

1

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 image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

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

Re: K031690 Trade/Device Name: Cynosure YAG Family Laser (PhotoGenica YAG, Acclaim) 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: May 30, 2003 Received: June 3, 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. Iisting 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) 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. 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) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 yours,

Miriam C. Provost

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

Page 1 of 1

510(k) Number (if known): _ KO31690

Device Name: _ Cynosure YAG Family Laser (PhotoGcnica YAG, Acclaim)

Indications For Use:

1064 nm: The Cynosure YAG Family laser is intended for the coagulation and hemostasis of bonion vascular lesions such as, but not limited to, port winc stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, stiae and psoriasis. The laser is also intended for the treatment of bonign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café' au lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

1320 nm The Cynosure YAG Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

and Neurological Devices

510(k) Number

Prescription Use

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)