(71 days)
Not Found
No
The summary describes a light-based curing device and does not mention any AI or ML components or functionalities.
No
The device is used to cure dental materials and bleaching formulations, not to diagnose, treat, or prevent disease in a patient.
No
Explanation: The device is described as a "Cure Light" used for "curing of photo-activated dental or photo-activated bleaching formulations". This indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "high intensity filtered light source, and optical delivery system," indicating it is a hardware device that emits light.
Based on the provided information, the Luma Light 2000 Cure Light is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for curing photo-activated dental and bleaching formulations in the mouth (implied by "dental practice situations" and "direct restorations, sealants, bonding agents and primers"). This is a direct treatment or procedure performed on a patient.
- Device Description: It describes a light source and delivery system for curing materials, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Luma Light 2000 Cure Light's function is to cure materials applied to teeth, which is a therapeutic or restorative action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems.
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)
Not Found
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.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
AUG 3 | 1999
に
510K Summary
Regulatory Authority: Safe Medical Devices Act of 1990. CFR 807.87
| Company Name: | ||
|---|---|---|
| Luma Lite, Inc. | ||
| 477 Marina Pkwy #400 | ||
| Chula Vista, CA 91910 | ||
| Company Contact: | ||
| Joe Forehand | ||
| Luma Lite, Inc. | ||
| 477 Marina Pkwy #400 | ||
| Chula Vista, CA 91910 | ||
| (619) 318-1251 | ||
| Device Name: | ||
| Luma Light 2000 Cure Light | ||
| Predicate Devices: | ||
| Kuring and Bleaching Light | K962376 | Kreativ, Inc. |
| Apollo 95E | K981948 | DMD |
| Pac Light | K952333 | American Dental Technologies |
Device and indications for use:
The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.
Discussion:
Since the intended use and technical specifications of the Luma Light 2000 Cure Light are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations, we believe that the Luma Light 2000 Cure Light is substantially equivalent to the predicate devices and can be marketed under Section 510 (k) of the FD&C Act.
1
Image /page/1/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 a stylized image of three human profiles facing right, with a flowing design that resembles a river or stream below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Mr. Joseph M. Forehand Vice President of Operations Luma Lite, Incorporated 477 Marina Parkway #400 Chula Vista, California 91910
Re: K992102 Luma Light 2000 Cure Light Trade Name: Requlatory Class: II Product Code: EBF June 16, 1999 Dated: Received: June 21, 1999
Dear Mr. Forehand:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Mr. Forehand
This letter will allow you to begin marketing your device as Inis receir will arion (k) premarket notification. The FDA described in your 510\n, promience of your device to a legally Finding of Subscancial Squr.
marketed predicate device results in a classification for your marketed predicate device rusatevice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpcorre additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on ebmpriance as (30 advertising of your device, please contact the Dffice of Compliance at (301) 594-4639. Also, please note the Orrice Or Compiland, "Misbranding by reference to the regaración Chouses, (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance oblained from cho mumber (800) 638-2041 or (301) 443-6597 or at at ICS COII-Tree namber (000)- 050 Eda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications Statement
11992102 510(k) Number:
Device Name:
Luma Light 2000 Cure Light
Indication for Use:
The Luma Light 2000 Cure Light is a high intensity filtered light The Luma Light 2000 Cure Light is a high induces curing of photosource, and optical centery system, castivated bleaching activated dental composites or proto-activersional light systems.
formulations at four (4) times the rate of conventional light systems. formulations at four (4) lines the rate of on on on on one of the material The Luma Light 2000 Cure Light Caros an phones
materials such as those used in direct restorations, sealants, matoling agents and primers.
Su
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
(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)
OR
Over the Counter Use_
Optional Format 1-2-96