(14 days)
Not Found
No
The document describes a laser and IPL system with various wavelengths and applications. There is no mention of AI or ML in the intended use, device description, or performance studies. The device appears to be a traditional energy-based medical device.
Yes
The device is described with numerous indications for use in medical procedures across various specialties, including surgical applications, dermatology, urology, and orthopedics, to treat a wide range of conditions and tissues. These uses fall under the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The Ultrawave III EX 1320 is a laser system intended for various surgical and aesthetic applications, including incision, excision, coagulation, hemostasis, vaporization, and ablation of soft tissue, as well as hair removal and treatment of skin lesions. Its function is to perform therapeutic procedures, not to diagnose medical conditions.
No
The device description clearly states it consists of laser sources, an IPL, power supply, cooling system, optical delivery system, and an integral skin cooler, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ultrawave III EX 1320 is a laser and IPL system used for various surgical and dermatological procedures performed directly on the patient's body. Its intended uses involve incision, excision, coagulation, hemostasis, vaporization, ablation, hair removal, wrinkle treatment, and treatment of various lesions and conditions. These are all in vivo procedures, not in vitro testing of specimens.
The description clearly outlines a device used for therapeutic and surgical interventions on living tissue, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Device Name: Ultrawave III EX 1320
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, gastrocnterology, 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 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 laser is also indicated for the treatment of facial wrinkles.
It 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).
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
It 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 bypass grafts, wedge resections, thoractomy, formation of pockets; vaporization, coagulation, pacemaker 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.
Nd:YAG 532nm
For the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremitics telangiectasias, venous anomalies, leg veins] : benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.
General Surgery:
Vaporizing, Coagulating, Incising , Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal homostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Woiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulccrs, Nonbleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and NecMOtorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis
Hemostasis during Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery:
Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma: AVMs: Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Ophthalmology:
Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
Thoracic Surgery:
Cutting (incision and excision), coagulating, and vaporizing of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractoniy, Formation of Pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation oflung tissue (Thoracoscopy )
Urology:
All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
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 laser 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Ultrawave III EX 1320 consists of two laser sources and an IPL. The laser sources emit wavelengths of 1064nm (long pulse and short pulse), 1320nm and 532nm for the Nd:YAG source and 755nm for the Alexandrite source. The IPI. has several different spectral ranges to be utilized for different applications: 400-1200nm, 550-1200nm, 570-1200nm, 590-1200nm, 625-1200nm and 650-1200nm. In addition, the Ultrawave III EX 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, dermatology/plastic surgery, gastrointestinal tract, head and neck/-otorhinolaryngology (ENT), eye (retina), pulmonary airway, lung tissue, intra-articular tissue, urinary bladder, external genitalia, hair follicles, skin, facial wrinkles, back, periorbital, perioral, vascular lesions, cutaneous lesions.
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)
Performance data was provided showing the Ultrawave III EX 1320 is capable of performing fractional photothermolysis, i.e., creation of pattern (lattice) of microscopic islets of damage at superficial skin layers.
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.
Quanta System S.p.A ULTRAWAVE II EX 1320 (K070805), Adept Medical Concept 1064/532/755 Laser (K032218)
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
(083207
510(k) SUMMARY Quanta System Ultrawave III EX 1320
Title:
NOV 1 4 2008
| Submitter: | Quanta System SpA
via IV Novembre,116
21058 Solbiate
Olona VA / Italy |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ไฟ | The The Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chil |
Dr. Isabella Carrer Contact: Medical Division Manager
| Date Prepared: | July 11, 2008 |
|---|---|
| Device Trade Name: | Quanta System Ultrawave III EX 1320 |
| Common Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification | |
| Name: | Instrument, surgical, powered, laser |
| Predicate Devices: | Quanta System S.p.A ULTRAWAVE II EX
1320 (K070805) Adept Medical Concept 1064/532/755 Laser |
| -------------------- | ------------------------------------------------------------------------------------------------ |
|---|
- (K032218)
| Intended Use/
| Indications for Use: | Device Name: | Ultrawave III EX 1320 |
|---|---|---|
| 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, gastrocnterology, general surgery, gynecology, head and neck/-otorhinolaryngology (ENT),
1
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 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 laser is also indicated for the treatment of facial wrinkles.
It 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).
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
It 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
2
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 bypass grafts, wedge resections, thoractomy, formation of pockets; vaporization, coagulation, pacemaker 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.
Nd:YAG 532nm
For the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremitics telangiectasias, venous anomalies, leg veins] : benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion
3
size.
General Surgery:
Vaporizing, Coagulating, Incising , Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Woiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Nonbleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and NecMOtorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis
Hemostasis during Surgery:
Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery:
Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma: AVMs: Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Ophthalmology:
Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery:
Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
4
Thoracic Surgery:
Cutting (incision and excision), coagulating, and vaporizing of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractoniy, Formation of Pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation oflung tissue (Thoracoscopy )
Urology:
All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
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
5
laser 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.
The Ultrawave III EX 1320 consists of two laser sources and an IPL. The laser sources emit wavelengths of 1064nm (long pulse and short pulse),1320nm and 532nm for the Nd:YAG source and 755nm for the Alexandrite source. The IPI. has several different spectral ranges to be utilized for different applications: 400-1200nm, 550-1200nm, 570-1200nm, 590-1200nm, 625-1200nm and 650-1200nm. In addition, the Ultrawave III EX 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.
Performance data was provided showing the Ultrawave III EX 1320 is capable of performing fractional photothermolysis, i.e., creation of pattern (lattice) of Performance Data microscopic islets of damage at superficial skin layers.
The Quanta System Ultrawave III EX 1320 is as safe and effective as the predicate devices. The Ultrawave III EX 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 III EX 1320 and its predicate devices raise no new issues of safety or effectiveness. Thus, the Ultrawave III EX 1320 is substantially equivalent.
Technological Characteristics:
Substantial Equivalence:
6
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2008
Quanta System S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25"1 Street Northwest Buffalo, Minnesota 55313
Re: K083207
Trade/Device Name: Ultrawave III 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: October 30, 2008 Received: October 31, 2008
Dear Mr. Job:
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
7
Page 2 - Mr. Mark Job
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
510(k) Number (if known): 1 083207
Ultrawave III EX 1320 Device Name:
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 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 laser is also indicated for the treatment of facial wrinkles.
It 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).
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K083207
\\DC - 028794/00001 - 2439941 vI
9
It 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 endarterectorny 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.
Nd:YAG 532nm
For the coagulation and hemostasis of vascular lesions.
Dermatology/Plastic Surgery:
Neil RP. Ogden for mxn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083207
2
10
For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins] : benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size.
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft Tissue as well as in Endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology:
Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal homostasis (including Varices, Esophagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulccrs, Non-bleeding Ulcers, Gastric Erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Head and NecMOtorhinolaryngology (ENT):
Tissue incision, excision, ablation, and vessel hemostasis
Hemostasis during Surgery:
Adiunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery.
Neurosurgery:
Hemostasis for: Pituitary Tumor, Meningioma; hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Ophthalmology:
Post-vitrectomy endophotocoagulation of the retina.
Pulmonary Surgery:
Neil RR Hyde for nxm
(Division Sign-C Division of General. Restorative, and Neurological Devices
510(k) Number K083207
3
11
Palliative treatment of benign and malignant pulmonary airway obstructions, including Squamous Cell Carcinoma, Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures.
Thoracic Surgery:
Cutting (incision and excision), coagulating, and vaporizing of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetomy and/or by-pass grafts, Wedge Resections, Thoractoniy, Formation of Pacemaker pockets. Vaporization, coagulation, incision and excision, debulking, and ablation oflung tissue (Thoracoscopy )
Urology:
All applications including: Superficial urinary bladder tumors, invasive bladder carcinoma; Urethral Strictures; Lesions of the external genitalia (including condyloma acuminata).
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).
Nilre Ogle for nxm
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number 085207
Integrated Skin Cooler
4
12
The intended use of the integrated cooling system in the laser 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter
(21 C,F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niel R.P. Ogle for mxm
(Division Sign-Ol Division of General, Restorative, and Neurological Devices
510(k) Number K083207