# Biolitec, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 29 (2001–2012): 28 510(k) clearances and 1 original PMA approval
- Product codes: GEX (28), MVF (1)
- Predicates its devices cite: 54 (22 its own); citations of its devices by later devices: 82 (22 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.: 8 (https://510kreport.com/company/ceram-optec)
- New Star Lasers, Inc.: 7 (https://510kreport.com/company/new-star-lasers)
- Quanta System Spa: 4 (https://510kreport.com/company/quanta-system)
- Intermedic Arfran, SA: 3 (https://510kreport.com/company/intermedic-arfran)
- Allmed Systems, Inc.: 3 (https://510kreport.com/company/allmed-systems)
- Cynosure, Inc.: 2 (https://510kreport.com/company/cynosure)
- Xintec Corporation, Dba,: 1 (https://510kreport.com/company/xintec-dba)
- Biolitec Medical Devices, Inc.: 1 (https://510kreport.com/company/biolitec-medical-devices)

## Firms that cite its devices most
- Xintec Corporation: 10 (https://510kreport.com/company/xintec)
- Biolitec Medical Devices, Inc.: 4 (https://510kreport.com/company/biolitec-medical-devices)
- Quanta System Spa: 4 (https://510kreport.com/company/quanta-system)
- Intermedic Arfran, SA: 3 (https://510kreport.com/company/intermedic-arfran)
- Beijing Star New Tech Co., Ltd.: 2 (https://510kreport.com/company/beijing-star-new-tech)
- Surgical Laser Technologies, Inc.: 2 (https://510kreport.com/company/surgical-laser-technologies)
- Litecure, LLC: 2 (https://510kreport.com/company/litecure)
- Biolase Technology, Inc.: 2 (https://510kreport.com/company/biolase-technology)

## Its most-cited devices
- K050824: 100W Ceralas D 980 Laser System, Model D100 (2005), cited by 9
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), cited by 8
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), cited by 7
- K072106: 150W Ceralas D 980NM Diode Laser (2007), cited by 6
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), cited by 6
- K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470 (2008), cited by 5

## Recent decisions
- K112013: Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser (Jan 13, 2012)
- K112253: Ceralas 147NM Diode Laser System (Sep 20, 2011)
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (Feb 24, 2011)
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (Dec 16, 2010)
- K101712: Endovascular Laer Vein System Kit (Oct 27, 2010)
- K100726: Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas HPD/ 980NM (Sep 15, 2010)
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (Jun 26, 2009)
- K083682: 180W Cerelas D 980NM Diode Laser, Model D180 (Jan 9, 2009)

Source page: https://510kreport.com/company/biolitec