(50 days)
Not Found
No
The device description focuses on a light source and delivery system with a timer, and there is no mention of AI, ML, or any data processing or analysis that would suggest the use of such technologies.
Yes
The device is described as providing "therapeutic light to the body" and is "generally indicated to treat dermatological conditions," specifically "moderate inflammatory acne vulgaris," which are all therapeutic uses.
No
Explanation: The device is described as providing "therapeutic light to the body" to "treat dermatological conditions" and "moderate inflammatory acne vulgaris." It is intended for therapy rather than diagnosis.
No
The device description clearly outlines hardware components including a desktop base unit, power supply, halogen bulb, timing pcb, and a Fibre Optic Probe delivery system. It is a physical light therapy device, not software.
Based on the provided information, the LumaCare LC-122M Non-coherent Light Source is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide therapeutic light to the body" and "treat dermatological conditions," specifically "moderate inflammatory acne vulgaris." This describes a therapeutic device that interacts directly with the patient's body for treatment.
- Device Description: The description details a light source and delivery system designed to apply light to the skin. It does not mention any components or processes related to examining specimens in vitro (outside of the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
In summary, the LumaCare LC-122M is a therapeutic device used for treating a condition on the body, not a diagnostic device used for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body
The LumaCare LC-122M Non-coherent Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The LumaCare LC-122M Non-coherent Light Source is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the wavelength range 400-440nm (blue) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic blue light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin treatment area
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)
Pre-clinical testing includes Electrical Performance Data: Safety and EMC testing including the requirements of IEC 60601-1:1988/A1/A2 "Medical electrical equipment - General requirements for safety" and "IEC 60601-1-2:2002 "Medical electrical equipment -General requirements for safety. Collateral standard - Electromagnetic compatibility. Requirements and tests"
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
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
K 062871
Appendix A6 The 510(k) Summary
| Applicant & Submitter : | Lynton Lasers Limited | NOV 14 2006 |
|---|---|---|
| Address : | Lynton House, Manor Lane, | |
| Holmes Chapel, Cheshire, CW4 8AF, UK | ||
| Telephone : | +44 (0)1477 536977 | |
| Fax : | +44 (0)1477 536978 | |
| Contact Person : | Dr. Andrew J Berry | |
| AJBerry@lynton.co.uk | ||
| Preparation Date : | 3rd July 2006 | |
| Device Submitted : | LumaCare LC-122M | |
| Non-coherent Light Source | ||
| Common Name : | Light Therapy Device | |
| Classification Name : | Laser surgical instrument for use in general | |
| and plastic surgery and in dermatology. | ||
| Product Code : | GEX | |
| Predicate Device : | BLU-U Blue Light Photodynamic Therapy | |
| Illuminator Model 4170, manufactured by | ||
| DUSA Pharmaceuticals, Inc. (K031805) | ||
| Device Description : | The LumaCare LC-122M Non-coherent | |
| Light Source is a high intensity lamp | ||
| intended for the therapy of dermatological | ||
| disorders such as moderate inflammatory | ||
| acne vulgaris by emitting visible light in the | ||
| wavelength range 400-440nm (blue) with | ||
| fluences of order 10-100mW/cm². The | ||
| principle parts of the system comprise of a | ||
| desktop base unit and a Fibre Optic Probe | ||
| (FOP) delivery system. The base unit | ||
| contains a mains supplied power supply unit | ||
| which powers a 250W halogen bulb, the | ||
| duration of the illumination being controlled | ||
| by a timing pcb with user-accessible | ||
| controls. The FOP delivery system | ||
| comprises of a ruggedised fibre bundle | ||
| assembly and (crucially) an optical filter | ||
| which selectively transmits only the | ||
| therapeutic blue light. A mechanical fixture |
1
is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
-
Intended Use : The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body
The LumaCare LC-122M Non-coherent Indications for Use : Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris. -
The pre-clinical testing includes Electrical Performance Data : Safety and EMC testing including the requirements of IEC 60601-1:1988/A1/A2 "Medical electrical equipment - General requirements for safety" and "IEC 60601-1-2:2002 "Medical electrical equipment -General requirements for safety. Collateral standard - Electromagnetic compatibility. Requirements and tests"
-
Substantial Equivalence : The LumaCare LC-122M Non-coherent Light Source is substantially equivalent to the previously cleared BLU-U Blue Light Photodynamic Therapy Illuminator Model The LumaCare LC-122M has the 4170. same intended use and the same general and specific indications for use as the BLU-U. The spectral output, mode of operation and general operating principles for the LumaCare LC-122M are similar to or the same as the BLU-U. The LumaCare LC-122M and the BLU-U are both light device that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are some differences in method by which each device produces light and is delivered to the treatment area. these differences do not raise new questions of safety of efficacy. Thus, the LumaCare LC-122M Non-coherent Light Source is substantially equivalent to the BLU-U.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. 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 emblem featuring an abstract design resembling an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lynton Lasers Limited % Dr. Andrew J. Berry Technical Director Lynton House, Manor Lane Holmes Chapel, Chesire CW 4 8 AF United Kingdom
Re: K062871
Trade/Device Name: LumaCare LC-122M Non-coherent Light Source 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: September 21, 2006 Received: September 25, 2006
NOV 1 4 2006
Dear Dr. Berry:
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 - Dr. Andrew J. Berry
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 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/industry/support/index.html.
Sincerely yours
Penh
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): K062871
LumaCare LC-122M Non-coherent Light Source Device Name:
Indications for Use: The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body
The LumaCare LC-122M Non-coherent Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris.
イ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Noh
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number l(a6287)