# K111901: Asa 'Mphi Family Diode Laser

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Nov 9, 2011 after 127 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ASA 'M Family' Diode Laser: named in the summary without a submission number

## Indications for use
The ASA 'Mphi Family' Diode Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle, and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Source page: https://510kreport.com/device/K111901
Methodology: https://510kreport.com/methodology