(110 days)
Not Found
Not Found
No
The summary describes a laser and IPL system with various wavelengths and intended uses for surgical and dermatological applications. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is clearly indicated for the treatment of various medical conditions and cosmetic issues, such as lesions, scars, wrinkles, and hair reduction, which falls under the definition of therapeutic applications.
No
The device is described as having therapeutic applications (e.g., incision, excision, coagulation, ablation, hair reduction, treatment of lesions and wrinkles) rather than diagnostic ones.
No
The device description clearly outlines hardware components such as laser sources, IPL, power supply, cooling system, optical delivery system, microprocessor-based controller, and an integral skin cooler. This indicates it is a physical medical device, not software-only.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that this device is a laser system (Nd:YAG, Alexandrite, and IPL) used for various surgical and dermatological procedures. These procedures involve direct interaction with the patient's body for treatment purposes (incision, excision, coagulation, hair removal, wrinkle treatment, etc.).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is to apply energy to the body for therapeutic or cosmetic effects.
Therefore, the intended use and device description align with a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
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:
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).
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, hair follicles, intra-articular tissue, pulmonary airway, lung tissue, urinary bladder, external genitalia, face
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)
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
§ 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
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 +39 0331 376797 Tel: Fax: +39 0331367815
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:
1
70805
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).
2
̄nōgos
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.
3
zozoj
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.
4
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.
5
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
6
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.
7
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
8
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)