Lapex 2000
FDA 510(k) K034009 · Meridian Co., Ltd.
Submission
- Device name
- Lapex 2000
- Applicant
- Meridian Co., Ltd.
Deer Field, IL, US - Received
- December 24, 2003
- Decision date
- January 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification…
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Questions and answers
When was Lapex 2000 cleared by the FDA?
Lapex 2000 (K034009) received a 510(k) decision of Substantially Equivalent on January 21, 2005, 394 days after the submission was received.
What is the product code of K034009?
The FDA product code is NHN – Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a Class II (moderate risk) device regulated under 21 CFR 890.5500.