TRISTAR AESTHETIC WORKSTATION LASER

K033176 · Cynosure, Inc. · GEX · Jan 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033176
• Device Name: TRISTAR AESTHETIC WORKSTATION LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal. 1064mm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous lesions such as but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/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 tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB). 1320 nm: The TriStar laser is indicated for use in gental surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

Device Story

TriStar Aesthetic Workstation combines pulsed dye laser and Nd:YAG laser in single unit; delivers energy via fiber optic cables; activated by foot switch. Operates at 585-600nm, 1064nm, and 1320nm wavelengths. Used in clinical settings by physicians for dermatological and surgical procedures. Laser energy targets melanin in hair follicles or vascular/cutaneous structures to achieve coagulation, hemostasis, or tissue ablation. Benefits include permanent hair reduction, lesion removal, and wrinkle treatment. System is 25 kg, 180x62x42 cm; requires 110 VAC power.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination pulsed dye and Nd:YAG laser system. Wavelengths: 585-600nm, 1064nm, 1320nm. Max energy: 60 J/cm2. Pulse width: 0-40 ms. Repetition rate: 1-3 Hz. Delivery via fiber optic cables. Electrical: 110 VAC, 15A, 50-60 Hz. Form factor: 180x62x42 cm, 25 kg.

Indications for Use

Indicated for patients requiring treatment of benign vascular/cutaneous lesions, tattoos, wrinkles, unwanted hair, and pseudofolliculitis barbae. Used for soft tissue incision, excision, ablation, vaporization, coagulation, and hemostasis in general surgery and dermatology.

Regulatory Classification

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.

Predicate Devices

• VLS-Star
• PhotoGenica YAG lasers

Submission Summary (Full Text)

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jan 2 1 2004

K033176 1 of 1

# 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | September 30, 2003 |
| Device Trade Name: | TriStar Aesthetic Workstation |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 |
| Equivalent Device: | VLS-Star and PhotoGenica YAG lasers |
| Device Description: | The TriStar laser is a combination of two laser devices; one pulse dye<br>laser and the other Nd:YAG laser. They are housed in the same box<br>with two separate laser energy delivery fibers.<br>Laser activation is by foot switch. Overall weight of the laser is 25 Kg,<br>and the size is 180x62x42 cm (HxWxD).<br>Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The TriStar laser is indicated for treatment of vascular lesions,<br>pigmentated lesions, tattoos, wrinkles and hair removal. |
| Comparison: | The TriStar laser is substantially equivalent to the predicated devices.<br>They have the same principle of operation, the same wavelength and<br>essentially the same power range as the predicate devices for the same<br>indications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The TriStar Aesthetic Workstation laser is another safe and effective<br>device for the intended applications. |
| Additional Information: | none |

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## Name of Manufacturer: Cynosure Inc. Laser Model Name and Number: Tristar Aesthetic Workstation Laser

Laser Type: (Circle all that apply)

Laser Type. (Carele an that appry) / apor, Diode, Dye Nd: YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other

### Indications in this application:

ations in this upprication. vascular lesions, treatment of wrinkles, long term hair removal. At 1320nm the laser is vascular testons, it eatment of willing of working one of the coagulation and hemostasis of soft midicated for use in general surgery and and wrinkles. (Please see Indications for Use Statement for more detailed list)

Statement for more detailed for benign vascular and vascular dependent lesions removal.

## FDA Document Control Number: K033176

FDA Product Code: 79GEX

Reviewer Computer Initials: CYH

Date of Clearance Letter: 01/16/04

Basis of Approval: (Circle all that apply)

Basis of Approvan: (Chrical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other ____________________________________________________________________________________________________________________

Description of Laser: Operation Modes: (Circle all that apply) Oper aron Modes: (Strels an and array), Contact, Free Beam, Other ____________________________________________________________________________________________________________

Wavelength in Nanometers: 585-600nm, 1064 nm, 1320nm

Power/Energy Range (Watts/Joules): max 60 J/cm2

Pulse Width: 0-40 ms

Repitition Rate: 1-3 Hz

Delivery System: Fiber optic cables Comments:

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human figures, possibly representing health, family, and community.

Public Health Service

JAN 2 1 2004

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, MA 01824-4145

Re: K033176 Trade/Device Name: TriStar Aesthetic Workstation Lascr Regulation Number: 21 CFR 878.4810 Regulation Name: Lascr surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: September 30, 2004 Received: December 29, 2004

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 gencral 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 cither class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can he 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 C'FR Part 801). please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

C'elia 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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510(k) Number (if known): _

K033176

Device Name: TriStar Aesthetic Workstation Laser

Indications For Use:

585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal.

1064mm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous lesions such as but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/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 tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

1320 nm: The TriStar laser is indicated for use in gental surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and 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)

Musiam C. Provost

ivision of Gene - I, Restorative sua Neurological Devices

K033176

Prescription Use V

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Over-The-Counter Usc

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