Lapex 2000

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K034009 ↗

FDA Product Code

NHN

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Laser Indirect Ophthalmoscope 500(Lio-500)

  Class II

  FDA 510(k) K113390 Active Cleared 14 Feb 2012

• Microrupter V

  Class II

  FDA 510(k) K023045 Active Cleared 26 Sep 2002

• Meridian-II and Merdian-Plus

  Class II

  FDA 510(k) K001347 Active Cleared 3 Nov 2000

• MR Q; MR Q Supine; MR Q Slt

  Class II

  FDA 510(k) K232417 Active Cleared 25 Jan 2024

• Abr-2000

  Class II

  FDA 510(k) K020360 Active Cleared 29 Aug 2002

• Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

  Class II

  FDA 510(k) K231011 Active Cleared 12 Sep 2023

See all devices from Meridian AG →

• What is the primary purpose of the Lapex 2000 in clinical settings and how does it differ from traditional thermal treatments for pain relief?

  The Lapex 2000 is a non-thermal laser instrument designed as an adjunctive therapy to complement pain management protocols, particularly for musculoskeletal conditions. Unlike traditional thermal treatments (e.g., heat or cold therapy), it delivers controlled light energy without generating heat, targeting temporary relief of localized discomfort as part of broader pain management strategies—not as a standalone solution.

• Is the Lapex 2000 intended for single-use or reusable applications, and what maintenance considerations should clinicians follow?

  The Lapex 2000 is reusable, requiring adherence to manufacturer guidelines for electrical safety and electromagnetic compatibility (EMC) compliance. Since it’s not invasive or sterile-dependent, sterility isn’t a requirement, but proper storage and handling are critical to ensure longevity and performance. Regular maintenance (e.g., cleaning and calibration) aligns with its classification as a durable medical instrument.

• How is the Lapex 2000 regulated, and what does its FDA clearance (K034009) imply about its intended use?

  The Lapex 2000 holds FDA 510(k) clearance (K034009) under the product code NHN (Non-Heating Laser for Pain Therapy), classified as a Class II device. Its clearance confirms it’s substantially equivalent to a predicate device, meaning it follows the same regulatory pathway without introducing new clinical indications. The approval is tied to its adjunctive, non-thermal role in pain management—specifically for musculoskeletal conditions—as outlined in the Physical Medicine advisory committee review.

• Are there specific storage requirements for the Lapex 2000, and does it require sterilization before use?

  The Lapex 2000 does not require sterilization due to its non-invasive, adjunctive design. However, storage must follow manufacturer instructions to preserve performance and safety. Since it’s reusable and electrical, it should be stored in a clean, dry environment away from moisture or extreme temperatures, as outlined in the device’s operational guidelines.

• What types of pain conditions is the Lapex 2000 most commonly used to support, and how does it integrate into existing treatment plans?

  The Lapex 2000 is primarily adjunctive for musculoskeletal pain conditions, aiding in temporary relief of localized discomfort as part of broader pain management protocols. It’s not intended to replace established therapies (e.g., medications, physical therapy) but rather to supplement them by delivering non-thermal laser energy. Clinicians typically use it in physical medicine settings where adjunctive, non-invasive interventions are part of the treatment strategy.