Axiom Biolaser Lllt SERIES-3
by Axiom Usa., Inc. 510(k)
Active
510(k) K033015
Overview
The Axiom Biolaser Lllt Series-3 is a Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy, as defined in its regulatory classification. It is a device indicated for use in physical medicine applications.
It is supplied as a reusable instrument and has received FDA 510(k) clearance under K033015. The device is regulated under 21 CFR 890.5500 with product code NHN and is classified as a Class II medical device for adjunctive use in pain therapy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033015 | Date25 Nov 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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
Other devices from Axiom Usa., Inc.
Questions
What is the Axiom Biolaser Lllt Series-3 used for?
The Axiom Biolaser Lllt Series-3 is indicated for adjunctive use in pain therapy within physical medicine applications, as a non-thermal laser instrument designed to provide therapeutic effects without heating tissue.
Is the Axiom Biolaser Lllt Series-3 reusable or single-use?
The device is supplied as a reusable instrument, meaning it can be cleaned and used multiple times according to the manufacturer's instructions for reuse, rather than being discarded after a single procedure.
What regulatory clearance does the Axiom Biolaser Lllt Series-3 have?
The Axiom Biolaser Lllt Series-3 received FDA 510(k) clearance under submission number K033015, confirming it is substantially equivalent to a legally marketed predicate device for its intended use.