# Polytec Pi, Inc.

- Location (FDA's records): Auburn, MA
- FDA decisions: 2 (1994–1997): 2 510(k) clearances
- Product codes: GEX (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spectrum Medical Technologies, Inc.: 1 (https://510kreport.com/company/spectrum-medical-technologies)

## Firms that cite its devices most
- Sandstone Medical Technologies, LLC: 1 (https://510kreport.com/company/sandstone-medical-technologies)

## Its most-cited devices
- K942343: Laseaway Q-Switched Ruby Laser System (1994), cited by 1
- K971193: Laseaway Long Pulse and Q-Switched Ruby Laser System (1997), cited by 1

## Recent decisions
- K971193: Laseaway Long Pulse and Q-Switched Ruby Laser System (Jun 24, 1997)
- K942343: Laseaway Q-Switched Ruby Laser System (Jul 8, 1994)

Source page: https://510kreport.com/company/polytec-pi