# Sharplan Lasers, Inc.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 78 (1986–1997): 78 510(k) clearances
- Product codes: GEX (66), LNK (4), LFL (2), GCJ (2), ITX (1), MGI (1), HET (1), HHR (1)
- Predicates its devices cite: 21 (7 its own); citations of its devices by later devices: 70 (7 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.: 2 (https://510kreport.com/company/spectrum-medical-technologies)
- Schwartz Electro-Optics, Inc.: 1 (https://510kreport.com/company/schwartz-electro-optics)
- Medical Laser Solutions: 1 (https://510kreport.com/company/medical-laser-solutions)
- Continuum Biomedical, Inc.: 1 (https://510kreport.com/company/continuum-biomedical)
- Aesculap-Meditec GmbH: 1 (https://510kreport.com/company/aesculap-meditec)
- Ion Laser Technology: 1 (https://510kreport.com/company/ion-laser-technology)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Thermolase Corp.: 1 (https://510kreport.com/company/thermolase)

## Firms that cite its devices most
- Lumenis, Inc.: 11 (https://510kreport.com/company/lumenis)
- Lasering S.R.L.: 8 (https://510kreport.com/company/lasering)
- Light Age, Inc.: 4 (https://510kreport.com/company/light-age)
- Phantom Technologies, Inc.: 4 (https://510kreport.com/company/phantom-technologies)
- Esc Medical Systems, Ltd.: 3 (https://510kreport.com/company/esc-medical-systems)
- Optomedic Medical Technologies, Ltd.: 3 (https://510kreport.com/company/optomedic-medical-technologies)
- Lutronic Corporation: 3 (https://510kreport.com/company/lutronic)
- Perception, Inc.: 2 (https://510kreport.com/company/perception)

## Its most-cited devices
- K971874: Sharplan Epitouch Alexandrite Laser System (5000) (1997), cited by 7
- K973354: Sharplan Epitouch Alexandrite Laser System (5000) (1997), cited by 7
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers (1996), cited by 7
- K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner (1996), cited by 5
- K935563: Sharplan Surgical CO2 Lasers and Accessories (1994), cited by 4
- K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner (1996), cited by 4

## Recent decisions
- K973354: Sharplan Epitouch Alexandrite Laser System (5000) (Dec 4, 1997)
- K972099: Sharplan Epitouch Ruby Laser System (Aug 27, 1997)
- K971874: Sharplan Epitouch Alexandrite Laser System (5000) (Aug 18, 1997)
- K971648: Sharplan Erbium: Yag Laser (4020) (Jul 23, 1997)
- K971743: Sharplan CO2 Surgical Laser System (Jul 18, 1997)
- K962446: Sharplan Ruby Laser System (Mar 7, 1997)
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers (Nov 5, 1996)
- K961935: Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner (Nov 1, 1996)

Source page: https://510kreport.com/company/sharplan-lasers