(229 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or data training/testing. The device description focuses on hardware features and basic automation (automatic head identification).
Yes
The "Intended Use / Indications for Use" section explicitly states "Dermatology for treatment of superficial, benign vascular, and pigmented lesions" and "specifically indicated to treat moderate inflammatory acne vulgaris," and "the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied," which are all therapeutic purposes. Additionally, the "Summary of Performance Studies" mentions "Performance Test Report for Temperature of therapeutic heat." The predicate devices also support the therapeutic nature of the device.
No
Explanation: The "Intended Use / Indications for Use" section describes the device's purpose for treatment of various conditions (vascular/pigmented lesions, acne vulgaris, muscle/joint pain, etc.) using different wavelengths of light. There is no mention of the device being used to identify, diagnose, or monitor a medical condition. The "Summary of Performance Studies" also references "therapeutic laser equipment," further indicating a treatment function rather than a diagnostic one.
No
The device description clearly states it is a "light therapy system" with "four type of head" and mentions hardware components like an "emergency switch" and "key switch," indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described (treatment of skin lesions, acne, muscle/joint pain, etc.) are all therapeutic applications performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description focuses on light therapy and its application to the body surface. There is no mention of analyzing biological samples.
- Lack of IVD-related terms: The document does not contain any terms typically associated with IVD devices, such as "specimen," "sample," "assay," "reagent," "diagnosis," or "in vitro."
- Predicate Devices: The listed predicate devices (Omnilux Revive, Omnilux Blue, Omnilux Plus) are all light therapy devices used for therapeutic purposes, not for in vitro diagnostics.
Therefore, the SMARTLUX device, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions
415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes
GEX
Device Description
SMARTLUX is light therapy system using two kinds of wave length light and infrared ray. It has four type of head which is including red, blue and IR respectively. Heads are chanqeable by user and assembled head is identified automatically after changing head and user interface is also changed according to each head. For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software:
SMARTLUX has ten type of heads for patient treatment. Below table shows the wave length of the light for each head.
Head Name | RED 633nm | BLUE 415nm | IR 830nm |
---|---|---|---|
SMARTLUX – RED | ° | ||
SMARTLUX – BLUE | ° | ||
SMARTLUX – IR | ° | ||
SMARTLUX - FX | ° | ° |
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)
Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment. Performance Test Report for Temperature of therapeutic heat The test data is attached
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
ડ. 510(k) Summary
OCT
1
See 510(k) Summary, below. Medmix Co., Ltd.
1310, Hanla Sigma Valley Bldg, #345-90, Gasan-dong, Geumcheon-gu,Seoul,153-802 Korea TEL. +82 (2) 6443-4000 FAX. +82 (2) 6443-4001 Website: www.medmix.co.kr
- Submission Correspondent: Peter Chunq
Tel 412-687-3976
Fax #: 412-687-3976 (Same with the home number)
Mobil phone #: 412-512-8802
Email address: pittcmi@hotmail.com
300 Atwood Street Pittsburgh, PA 15213 USA
Date: May 12th, 2012
2. Trade Name: . SMARTLUX
Common Name : Visible and Infrared Light Source Product Code: GEX Regulation: 878.4810 Class of device : ClassII.
3. Description of device:
SMARTLUX is light therapy system using two kinds of wave length light and infrared ray.
It has four type of head which is including red, blue and IR respectively.
Heads are chanqeable by user and assembled head is identified automatically
after changing head and user interface is also changed according to each head.
For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software:
· Head type
SMARTLUX has ten type of heads for patient treatment. Below table shows the wave length of the light for each head.
| Head Name | RED
633nm | BLUE
415nm | IR
830nm |
|-----------------|--------------|---------------|-------------|
| SMARTLUX – RED | ° | | |
| SMARTLUX – BLUE | | ° | |
| SMARTLUX – IR | | | ° |
| SMARTLUX - FX | ° | | ° |
4. Predicate Devices
- Wave length of red head in SmartLux are 633nm and pulse type is continuous which are . equal with Omnilux Revive(K030426)
1
5. 510(k) Summary
- Wave length of blue head in SmartLux are 415nm and pulse type is continuous which are . equal with Omnilux Blue (K030883)
- Wave length of IR, FX head in SmartLux are 830 nm and pulse type is continuous which are equal with Omnilux Plus (K043317)
5. Intended use
633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions
415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
6. Performance test
- Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment
. Performance Test Report for Temperature of therapeutic heat The test data is attached
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 stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
1
2012
Medmix Company, Limited % Mr. Peter Chung President 300 Atwood Pittsburgh, Pennsylvania 15213
Re: K120460
Trade/Device Name: SMARTLUX 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 18, 2012 Received: September 26, 2012
Dear Mr. Chung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Peter Chung
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Mulkerss
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K120460
Device Name: Visible and Infrared Light Source
Indications For Use:
633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions
415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120460
Page 1 of 1