(394 days)
No
The summary describes a low-level laser therapy device and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome, which is a therapeutic application.
No
Explanation: The device is indicated for adjunctive use in temporary pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "low level laser therapy device," which is a hardware-based technology.
Based on the provided information, the LAPEX-2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a low level laser therapy device, which is a physical therapy modality, not a device used to examine specimens from the human 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 markers of disease, or providing diagnostic information.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The LAPEX-2000's function is to apply energy to the body for therapeutic effect.
N/A
Intended Use / Indications for Use
The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Product codes
NHN
Device Description
The LAPEX-2000 is a low level laser therapy device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
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)
The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Meridian Co. Ltd.. that the Lapex 2000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
JAN 2 1 2005 K034009 1/2
EXHIBIT 2 510(k) Summary Meridian Co., Ltd.. 4FL., Hongsung Bldg. 197-3 Jamsil-Dong, Songpa-Gu, Seoul 138-220 Korea 82-2-2103-3300 Phone: 82-2-2103-3333 Fax: November 22, 2004
Contact: Soorang Lee, R&D Director
- l . Identification of the Device: Proprietary-Trade Name: Lapex 2000 Classification Name: Lamp, non-heating, for adjunctive use in pain therapy NHN Common/Usual Name: Infrared Lamp
- Equivalent legally marketed devices LAPEX-2000 is substantially equivalent to other low 2. level therapeutic lasers currently in commercial distribution. These predicate devices include THOR International Ltd. THOR DDII 830CL3 Laser System (K030226),and the MicroLight 830 (K010175). The LAPEX-2000 has same intended use as and similar technological characteristics to these predicate devices.
-
- Indications for Use (intended use) The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
| Semiconductor Laser
| Therapy System | • Non-invasive digital semiconductor laser therapy |
|---|---|
| Safe treatment | • Non-invasive therapy type |
| • Non-painful & security therapy for a patient | |
| Light and portable | • A small volume by using semiconductor laser diodes |
| • Easy operation and portable | |
| User friendly operation | • Therapy information display on LCD monitor |
| • Easy key operation |
- Description of the Device: The LAPEX-2000 is a low level laser therapy device. 4.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
1
K034009 2/2
| Feature | LAPEX-2000 | Predicates | |
|---|---|---|---|
| THOR DDII 830CL3 Laser | |||
| System (K030226) | MicroLight | ||
| 830, (K010175) | |||
| PROBE | |||
| Source | Diode GaAlAs | Diode GaAlAs | Diode GaAlAs |
| Type | Continuous & | ||
| Modulated Continuous | Continuous & | ||
| Modulated Continuous | Continuous & | ||
| Modulated Continuous | |||
| Wavelength | 830nm | 830nm | 830nm |
| Output Power | 30mW x 3 | 30mW x 3 | 30mW x 3 |
| Intended use | The LAPEX-2000 is | ||
| indicated for | |||
| adjunctive use in the | |||
| temporary relief of | |||
| hand and wrist pain | |||
| associated with Carpal | |||
| Tunnel Syndrome | The THOR DDII 830CL3 | ||
| Laser System is non- | |||
| Heating infrared lamp and | |||
| is indicated for | |||
| adjunctive use in the | |||
| temporary relief of | |||
| hand and wrist pain | |||
| associated with carpal | |||
| tunnel syndrome | Adjunctive use in the | ||
| temporary relief of | |||
| hand and wrist pain | |||
| associated with Carpal | |||
| Tunnel Syndrome |
Substantial Equivalence Chart
7. Conclusion
After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Meridian Co. Ltd.. that the Lapex 2000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile. The symbol is black and the background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2005
Meridian Company, Ltd. c/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K034009
Trade/Device Name: Lapex 2000 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to trg. 3)
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the exactions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Cosmetic 710-1710-11-18, that do novice, subject to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is elassified (boo are rotrols. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that FDA issuance verour device complies with other requirements of the Act that I DT has made a about regulations administered by other Federal agencies. You must or any I cacial statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (Dr CFR Part 820); and if applicable, the electronic forth in the quality bybells (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Daniel Kamm, P.E.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his ietter will anow you to oegin manteanig your and equivalence of your device to a legally premarket nothcation. The PDA maing of backanial reportunation of 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 If you desire specific acvice for your acon (240) 276-0115. Also, please note the regulation entitled, p Colliact the Office of Compitalion in (21CFR Part 807.97). You may obtain Missuranting by Iciercher to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
Indications for Use
K034009 510(k) Number (if known):_
Device Name:
Indications For Use: The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
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)
Page 1 of 1
uriam C. Parvost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________