(90 days)
Not Found
No
The document describes a laser system with standard components and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes
The device is indicated for the treatment of various medical conditions such as vascular lesions, scars, psoriasis, and warts, which are medical treatments aimed at improving health or alleviating symptoms.
No
Explanation: The device description and intended use clearly state that the NLite System is for "treatment" of various skin conditions, not for diagnosis. It is a pulsed dye laser used to therapeutically address lesions.
No
The device description clearly outlines hardware components such as a laser console, fiber optic delivery device, handpiece, and footswitch, indicating it is a hardware-based medical device.
Based on the provided information, the NLite System laser system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "Dermatological and Plastic Surgery applications" and is used for treating various skin conditions and lesions. This involves direct treatment of the patient's body.
- Device Description: The description details a laser system with components like a laser resonator, optics, delivery device, and handpiece. This is consistent with a therapeutic device used externally on the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples and provide diagnostic information. The NLite System is a therapeutic device used in vivo (on the living body) for treatment.
N/A
Intended Use / Indications for Use
The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
Product codes
GEX
Device Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; .
- Footswitch for pulsing control. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal region of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialties of Dermatology and Plastic Surgery
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
JUN 0 4 2002
510(k) Submission for the ICN Photonics Ltd., Nlite System
IBNE
ICN Photonics Ltd.
510(k) Summary Statement. ICN Photonics Ltd., Nlite System
1. General Information.
| Submitter: | ICN Photonics Ltd
Units 1 & 2 Heol Rhosyn
Dafen Parc,
Llanelli,
Carmarthenshire,
Wales,
UK, SA14 8QG |
| ------------ | ------------------------------------------------------------------------------------------------------------------------ |
|---|
Contact : Ian Mortimer - Regulatory and Quality Manager.
Summary Preparation date : 28 Feb 2002
2. Names :
Device Name : Nite System
Primary Classification Name : Laser Powered Surgical Instrument.
3. Predicate Devices :
K013043 - Candela Clearbeam Pulse Dye Laser System K921842 - Cynosure. Photogenica V Pulsed Dye Laser.
4. Product Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; .
- Footswitch for pulsing control. .
1
510(k) Submission for the ICN Photonics Ltd., Nlite System
020729 2/2
IGN
ICN Photonics Ltd.
5. Indications for Use
The NLite system is indicated for use in the specialties of Dermatology and Plastic Surgery applications, and in particular for the treatment of Vascular lesions, such as Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
6. Rationale for Substantial Equivalence
The key laser parameters, namely wavelength, pulse duration, energy density and delivery mechanism, produced by the NLite System are equivalent to both the predicate devices. The specific indications for use for the NLite System are identical that of the predicate. There is an identical interaction in the specific targeting of the Vasculature within the dermal region of the skin. The predicate devices are intended to produce permanent damage to the vasculature as is the NLite System.
As far as technological considerations are concerned, the NLite System utilizes the same design principles as the predicate devices, namely the method of producing the laser output is identical. More specifically, the laser output parameters and delivery method are equivalent in nature to those provided by the predicate devices.
7. Safety and Efficacy Information
None required -- The precise equivalence to predicate devices negate the need to support additional efficacy information.
8. Conclusion
The NLite System has been found to be substantially equivalent to the predicate devices, specifically in technological design resulting in identical desired physiological interactions. The design and manufacture of the device is in accordance with the relative international standards and the potential risk to operator and patient has been minimized.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ian Mortimer Regulatory and Quality Manager ICN Photonics Ltd. Units 1 & 2 Heol Rhosyn Dafen Parc Llanelli. Carmarthenshire Wales United Kingdom, SA14 8QG
JUN 0 4 2002
Re: K020729 Trade/Device Name: ICN Photonics Ltd. NLite System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 28, 2002
Dear Mr. Mortimer:
Received: March 6, 2002
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. Iisting 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.
3
Page 2 - Mr. Ian Mortimer
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dr. Mark N. Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission for the ICN Photonics Ltd., NLite System
IGN
ICN Photonics Ltd.
Section 4 Indications for Use Statement as Requested by FDA
510(k) Number (if known): K020729
Device Name: ICN Photonics Ltd., NLite System
Indications for Use:
The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Section 4 14.02.01
OR
for Mark N. Mullaneon
Division Sign-Off
Over-The-Counter Use
vision of General. Restorative
510(k) Number _K02729
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