ULTRAWAVE II EX 1320

K070805 · Quanta System Spa · GEX · Jul 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070805
• Device Name: ULTRAWAVE II EX 1320
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Nd:YAG 1064nm Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics. General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis . It addition, the laser is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos), and plaques. The ULTRAWAVE II EX 1320 laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The ULTRAWAVE II EX 1320 laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The ULTRAWAVE II EX 1320 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). The ULTRAWAVE II EX 1320 is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The ULTRAWAVE II EX 1320 is indicated for use on all skin types (Fitzpatrick I-VI.) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obtructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate). Nd:YAG 1320nm Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars. Alexandrite 755nm Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles. IPL 590-1200nm ; 625-1200nm; 650-1200nm Indicated for permanent hair reduction. 550-1200nm ; 570-1200nm Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. 400-1200nm Indicated for inflammatory acne (acne vulgaris). Integrated Skin Cooler The intended use of the integrated cooling system in the ULTRAWAVE II EX 1320 hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Device Story

Multi-source laser/IPL system; includes Nd:YAG (1064nm/1320nm), Alexandrite (755nm), and IPL (various spectra 400-1200nm). Device utilizes microprocessor-based controller to manage energy delivery via optical handpieces. Integrated skin cooler provides pre-treatment cooling to reduce pain and thermal side effects, enabling higher fluences. Operated by clinicians in surgical/dermatological settings. Output is controlled light energy for tissue interaction (ablation, coagulation, photothermolysis). Benefits include precise tissue management, permanent hair reduction, and treatment of various dermatological/surgical pathologies.

Clinical Evidence

No clinical data.

Technological Characteristics

Multi-source system: Nd:YAG (1064nm, 1320nm), Alexandrite (755nm), and IPL (400-1200nm). Includes power supply, optical delivery system, microprocessor-based controller, and integrated skin cooler. Safety features ensure correct wavelength/handpiece selection.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, coagulation, hemostasis, vaporization, or ablation across general, plastic, endoscopic, laparoscopic, gynecological, ENT, neurosurgical, oculoplastic, orthopedic, pulmonary, thoracic, and urological procedures. Also indicated for dermatological conditions including vascular/pigmented lesions, hair removal, acne, and wrinkles in Fitzpatrick skin types I-VI.

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

• Adept Medical Concept's Adept 1064/755 Laser
• Sciton, Inc.'s Profile 1320 Laser
• Altus Medical Inc.'s Altus Medical Coolidge Laser Systems and Accessories
• Quanta System's Eterna Giovinezza System
• Cynosure's YAG Family of Lasers
• Cynosure Apogee Elite laser

Submission Summary (Full Text)

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070805

JUL I I 2007

# 510(k) SUMMARY

#### Quanta System's ULTRAWAVE II EX 1320

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Quanta System SPA Via IV Novembre , 116 Solbiate Olona (VA) Italy 21058 [phone] Tel: Fax: [phone]

Contact Person: Isabella Carrer

Date Prepared: March 9, 2007

#### Name of Device and Name/Address of Sponsor

ULTRAWAVE II EX 1320 Quanta System SPA Via IV Novembre, 116 Solbiate Olona (VA) Italy 21058

#### Common or Usual Name

Laser surgical instrument for us e in general and plastic surgery and in dermatology

#### Classification Name

Surgical powered laser instrument

#### Predicate Devices

- Adept Medical Concept's Adept 1064/755 Laser .
- Sciton, Inc.'s Profile 1320 Laser .
- Altus Medical Inc.'s Altus Medical Coolidge Laser Systems and Accessories .
- Quanta System's Eterna Giovinezza System .
- Cynosure's YAG Family of Lasers .
- Cynosure Apogee Elite laser ●

#### Intended Use / Indications for Use

#### Nd:YAG 1064nm

Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics.

### General Surgical Applications:

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Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology.

### Dermatology/Plastic Surgery:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, ven us lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis . It addition, the laser is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos), and plaques.

The ULTRAWAVE II EX 1320 laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The ULTRAWAVE II EX 1320 laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The ULTRAWAVE II EX 1320 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).

The ULTRAWAVE II EX 1320 is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The ULTRAWAVE II EX 1320 is indicated for use on all skin types (Fitzpatrick I-VI.) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

# Orthopedics:

Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

### Pulmonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obtructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

# Thoracic Surgery:

Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

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### Urology:

All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate).

### Nd:YAG 1320nm

Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars.

### Alexandrite 755nm

Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles.

### IPL

### 590-1200nm ; 625-1200nm; 650-1200nm

Indicated for permanent hair reduction.

# 550-1200nm ; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

### 400-1200nm

Indicated for inflammatory acne (acne vulgaris).

### Integrated Skin Cooler

The intended use of the integrated cooling system in the ULTRAWAVE II EX 1320 hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Any other different use is considered incorrect.

### Technological Characteristics

The ULTRAWAVE II FX 1320 consists of two laser sources and an IPL. The laser sources emit wavelengths of 1064nm,1320nm for the Nd:YAG source and 755nm for the Alexandrite source. The IPL has several different ULTRAWAVE II FX 1320 includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; an integral skin cooler; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

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Performance Data

None.

# Substantial Equivalence

The ULTRAWAVE II FX 1320 is as safe and effective as the predicate devices. The ULTRAWAVE II FX 1320 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ULTRAWAVE II FX 1320 and its predicate devices raise no new issues of safety or effectiveness. Thus, the ULTRAWAVE II FX 1320 is substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 1 2007

Quanta System, SpA % Hogan & Hartson, LLP Mr. Jonathan S. Kahan 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K070805

Trade/Device Name: ULTRAWAVE II EX 1320 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 3, 2007 Received: May 3, 2007

Dear Mr. Kahan:

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. Jonathan S. Kahan

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 [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/ipdustry/support/index.html.

Sincerely

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): k070805

Device Name: ULTRAWAVE II EX 1320 Indications for Use:

# Nd:YAG 1064nm

Intended for general surgical applications; dermatology/plastic surgery; endoscopic/laparoscopic surgery; general surgery; gynecology; ENT; hemostasis; neurosurgery; oculoplastics; pulmonary surgery; thoracic surgery; urology; and orthopedics.

# General Surgical Applications:

Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology. general surgery, gynecology, head and neck/-otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology.

#### Dermatology/Plastic Surgery:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins and poikiloderma of Civatte and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis . It addition, the laser is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of blue and/or black tattoos), and plaques.

The ULTRAWAVE II EX 1320 laser is also indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The ULTRAWAVE II EX 1320 laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The ULTRAWAVE II EX 1320 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).

The ULTRAWAVE II EX 1320 is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The ULTRAWAVE II EX 1320 is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

#### Orthopedics:

Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.

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70 805

### Pulmonary Surgery:

Palliative treatment of benign and malignant pulmonary airway obtructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

### Thoracic Surgery:

Incision, excision, coagulating and vaporization of soft tissue. Thoracic applications, including but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (thoracoscopy).

### Urology:

All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitalia (including condyloma acuminate).

### Nd:YAG 1320nm

Indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars.

#### Alexandrite 755nm

Intended for coagulation and hemostatis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. Also indicated for pigmented lesions and wrinkles.

#### IPL

#### 590-1200nm ; 625-1200nm; 650-1200nm

Indicated for permanent hair reduction.

# 550-1200nm ; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion ( i.e.,face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

#### 400-1200nm

Indicated for inflammatory acne (acne vulgaris).

#### Integrated Skin Cooler

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The intended use of the integrated cooling system in the ULTRAWAVE II EX 1320 hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Any other different use is considered incorrect.

(Division Sign-Off)
**Division of General, Restor**

and Neurological Devices

**510(k) Number** 120

Prescription Use X (Part 21 C.F.R. 801 Subpart D) Subpart C)

AND / OR

Over-The-Counter Use (21 C.F.R. 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)