# Biolitec Medical Devices, Inc.

- Location (FDA's records): Grandville, MA
- FDA decisions: 9 (2011–2012): 9 510(k) clearances
- Product codes: GEX (9)
- Predicates its devices cite: 15 (0 its own); citations of its devices by later devices: 9 (0 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
- Ceram Optec, Inc.: 9 (https://510kreport.com/company/ceram-optec)
- Biolitec, Inc.: 4 (https://510kreport.com/company/biolitec)
- Hogan & Hartson: 2 (https://510kreport.com/company/hogan-hartson)

## Firms that cite its devices most
- Med-Fibers, Inc.: 2 (https://510kreport.com/company/med-fibers)
- G.N.S Neolaser, Ltd.: 1 (https://510kreport.com/company/gns-neolaser)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)
- Biolitec Sia: 1 (https://510kreport.com/company/biolitec-sia)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Biolitec, Inc.: 1 (https://510kreport.com/company/biolitec)
- Biolitec Sia (Latvia): 1 (https://510kreport.com/company/biolitec-sia-latvia)
- Asclepion Laser Technologies GmbH: 1 (https://510kreport.com/company/asclepion-laser-technologies)

## Its most-cited devices
- K113858: Megabeam Endo-Ent Probe (2012), cited by 2
- K112987: Twister Side Fire Optical Fiber Delivery System (2011), cited by 2
- K112324: Ceralas 980NM Diode Laser Family (2011), cited by 2
- K113792: Megabeam Endocular Probe and Aspirating Endocular Probe (2012), cited by 1
- K112299: Endovascular Laser Vein System Kit (2011), cited by 1
- K120231: Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) (2012), cited by 1

## Recent decisions
- K120231: Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual) (Apr 24, 2012)
- K113688: Megabeam Reusable Fiber Optic Delivery System (Mar 13, 2012)
- K113858: Megabeam Endo-Ent Probe (Jan 24, 2012)
- K113709: Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece (Jan 20, 2012)
- K113792: Megabeam Endocular Probe and Aspirating Endocular Probe (Jan 19, 2012)
- K112987: Twister Side Fire Optical Fiber Delivery System (Dec 16, 2011)
- K112299: Endovascular Laser Vein System Kit (Nov 3, 2011)
- K112442: Radial-Emitting Shaped Fiber Optic Delivery System (Sep 30, 2011)

Source page: https://510kreport.com/company/biolitec-medical-devices