(91 days)
Not Found
No
The description focuses on the hardware components of a laser system and does not mention any software or algorithms that would suggest AI/ML.
Yes
The device is indicated for the treatment of wrinkles, which makes it a therapeutic device.
No
The device is described as a laser system intended for the treatment of wrinkles, not for diagnosing any condition.
No
The device description explicitly lists hardware components such as a main laser console, fiber optic delivery device, optical handpiece, and footswitch, indicating it is a hardware-based medical device.
Based on the provided information, the NLite System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of wrinkles in the specialties of Dermatology and Plastic Surgery. This is a therapeutic application performed directly on a patient's body.
- Device Description: The device is a laser system used for treatment, not for analyzing biological samples outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NLite System's function is entirely different.
N/A
Intended Use / Indications for Use
The NLite system is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of wrinkles.
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.
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
Not Found
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)
Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ICN Photonics Ltd NLite System, cleared August 2000, 510(k) approval ● number K000811.
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
Image /page/0/Picture/1 description: The image shows a logo with the word "IOWA" stacked vertically. The letters are bold and black, with a stylized design. The "A" in "IOWA" has a triangular shape at the top, resembling a roof or peak. The overall design is simple and modern.
013461 1/2
510(k) Summary Statement ICN Photonics NLite System
'JAN 1 7 2002
1. General Information
- ICN Photonics Ltd Submitter: Units 1&2 Heol Rhosyn Dafen Parc Llanelli, Carmarthenshire Wales, UK, SA14 8QG
Dr Mike Kiernan – Director of Clinical Research Contact Person:
Summary Preparation Date: October 17th 2001
2. Names
Device Name: NLite System
Primary Classification Name: Laser Powered Surgical Instrument
3. Predicate Devices
- ICN Photonics Ltd NLite System, cleared August 2000, 510(k) approval ● number K000811.
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. .
5. Indications for Use
The NLite system is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of wrinkles.
1
K 013461 2/2
510(k) Submission Expansion of NLite Claims
Image /page/1/Picture/2 description: The image shows a logo with the letters "ICME" stacked vertically. The letters are bold and black, with a stylized design. The letter "E" at the bottom has a unique shape, resembling a plus sign with a circle in the center. The logo appears to be for an organization or company with the acronym ICME.
6. Rationale for Substantial Equivalence
The laser system described in this submission is cleared for marketing under 510(k) approval K000811, August 2000. No modifications to the laser system have been undertaken.
7. Safety and Efficacy Information
Clinical data has been provided to demonstrate that the NLite system is safe and effective for the described indications for use.
8. Conclusion
The NLite system has been found to be substantially equivalent to the predicate devices, specifically in technological design and operation and similar in nature to the 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 have been minimized.
The clinical data provided has demonstrated that the specific indications for use is met and the safety and efficacy of the system has been proved.
-
-
- 1
-
2
Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Michael Kiernan Director of Clinical Research ICN Photonics, Ltd. Units 1 & 2 Heol Rhosyn Dafen Parc Llanelli, Carmarthenshire SA14 8OG Wales, UK
JAN 1 7 2002
Re: K013461
Trade/Device Name: 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: October 17, 2001 Received: October 18, 2001
Dear Dr. Kiernan:
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 (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.
3
Page 2 - Dr. Michael Kiernan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and the FDA finding of substantial equivalence of your device to a legally premaince no ice 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 additionally 21 21 31 3 3 3 3 3 3 3 3 4 5 - 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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 yours,
Sincerely yours,
Mark N Millerson
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
Image /page/4/Picture/1 description: The image shows a logo with the letters "ICN" in bold, black font on the left side. To the right of the letters are three stacked symbols. The top symbol appears to be a flask, the middle symbol is a recycling symbol, and the bottom symbol is a radiation symbol. The logo is simple and uses a limited color palette.
Indications for Use Statement as Requested by FDA
KO13461 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ No
Device Name: NLite System
Indications for Use:
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
fo Mark n Millhuser
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________