(14 days)
Not Found
No
The description focuses on the hardware components and manual adjustments via a touch screen. There is no mention of AI, ML, or any automated decision-making or learning capabilities. The software mentioned appears to be for control and operation, not for AI/ML functions.
Yes
The device is indicated for the treatment of various medical conditions such as benign pigmented lesions, benign cutaneous lesions (warts, scars, striae), and benign cutaneous vascular lesions, which are therapeutic applications.
No.
The "Intended Use / Indications for Use" section describes the device for "treatment" of various conditions, such as pigmented lesions, vascular lesions, and hair removal, rather than for diagnosing them.
No
The device description explicitly states it is composed of a console, power supply, electronic circuit board, cooling system, LCD screen, handpiece, and footswitch, all of which are hardware components. While it is controlled by software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical, aesthetic and cosmetic applications requiring selective photothermolysis... of soft tissue". This describes a therapeutic or cosmetic treatment applied directly to the patient's body.
- Device Description: The description details a system that delivers light energy to the body via a handpiece. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to treat conditions on the body directly.
N/A
Intended Use / Indications for Use
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles)
- Benign cutaneous lesions including warts, scars, and striae
560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of:
- The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of:
- The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
Product codes
GEX
Device Description
The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, cutaneous, facial, truncal, leg
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K082033 JUL 3 1 2008
510(k) Summary
:
Global USA Distribution, LLC NannoLight Intense Pulsed Light System 510(k) Premarket Notification
| Submitter: | Global USA Distribution, LLC |
|---|---|
| Address: | 10723 Aquila Av. S. |
| Minneapolis, MN 55438 | |
| Contact Person: | Matt Makousky |
| Telephone: | 952-703-5373 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | April 1, 2008 |
| Device Trade Name: | NannoLight Intense Pulsed Light System |
| Classification Name: | Instrument, Powered, Laser |
| 79-GEX, 21 CFR 878.4810 | |
| Legally Marketed Predicate | |
| Devices: | Sciton Profile BBL System (K032460), |
| Lumenis Family of Intense Pulsed-Light (IPL) and | |
| IPL/Nd:YAG Laser Systems (K020839) |
Description of the NannoLight Intense Pulsed Light System:
The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.
1
Intended Use of the NannoLight Intense Pulsed Light System:
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles)
- Benign cutaneous lesions including warts, scars, and striae
560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of:
- The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of:
- The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
| Nonclinical Performance
| Data: | None |
|---|---|
| Clinical Performance | |
| Data: | None |
| Additional Information: | None requested at this time |
| Conclusion: | The NannoLight Intense Pulsed Light System is |
| substantially equivalent to other existing legally | |
| marketed laser systems currently in commercial | |
| distribution. |
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096
JUL 3 1 2008
Re: K082033
Trade/Device Name: NannoLight Intense Pulsed Light System 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: July 15, 2008 Received: July 17, 2008
Dear Mr. Devine:
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
3
Page 2 -- Mr. Ned Devine
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 N. Mullean
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ ( 082 0 33
Device Name: NannoLight Intense Pulsed Light System
Indications for Use:
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of;
-
- Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles)
- Benign cutaneous lesions including warts, scars, and striae
560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Benign cutaneous lesions including warts, scars, and striae
640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction.
Prescription Use: AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millbern
on of General, Restorative, and Neurological Devices
510(k) Number K082033