Acculaser PRO4
510(k) K023060
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023060 | Date19 Mar 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHN
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Acculaser Pro4 is a powered, light-based laser instrument designed for non-thermal adjunctive use in pain therapy. Classified as a Class II device, it emits non-heating infrared energy at 830 nm to target tissues, providing a non-invasive approach for temporary pain relief. Its mechanism relies on low-level laser therapy (LLLT) to modulate physiological responses without thermal effects. The device is intended for clinical applications within physical medicine settings.
The Acculaser Pro4 is supplied as a reusable medical device and is intended for use in clinical environments by trained healthcare providers. It requires no sterilisation between uses but must be maintained according to manufacturer guidelines to ensure safety and efficacy. The device has received FDA 510(k) clearance under the traditional review pathway, with a classification of Substantially Equivalent (SESE) to a predicate device. No specific MRI safety information is provided, and its use should adhere to standard laser safety protocols.
Other devices from Acculaser, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Acculaser Pro4 used for in clinical settings?
The Acculaser Pro4 is a powered, non-thermal laser instrument designed for adjunctive use in pain therapy. It emits low-level infrared energy at 830 nm to provide temporary pain relief through non-invasive, non-heating mechanisms. This approach is intended to modulate physiological responses without causing thermal damage, making it suitable for physical medicine applications.
Is the Acculaser Pro4 a single-use or reusable device?
The Acculaser Pro4 is a reusable medical device. While it does not require sterilization between uses, it must be maintained according to the manufacturer’s guidelines to ensure safety and effectiveness. Proper cleaning and upkeep are essential to preserve its performance and longevity.
Does the Acculaser Pro4 require any special storage conditions?
The device should be stored in a clean, dry environment following the manufacturer’s instructions. Since it is reusable and not sterile, it should be kept in a way that prevents contamination and damage. Specific storage details, such as temperature or humidity requirements, are not provided in the available data, so adherence to general medical device maintenance protocols is recommended.
What regulatory pathway was followed for FDA clearance of the Acculaser Pro4?
The Acculaser Pro4 received FDA clearance under the traditional review pathway as a Class II device. It was classified as Substantially Equivalent (SESE) to a predicate device, meaning it was determined to have the same intended use, technological characteristics, and performance as a previously cleared device. This classification is reflected in its FDA 510(k) clearance.
Are there any known safety considerations for using the Acculaser Pro4 near MRI equipment?
The available data does not provide specific MRI safety information for the Acculaser Pro4. If used in an environment with MRI equipment, standard laser safety protocols should be followed, and the device should not be brought into the MRI scanning area unless confirmed safe by the manufacturer or MRI facility guidelines. Always consult the manufacturer’s instructions for safe operation.