# Ceram Optec, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 30 (1992–2000): 30 510(k) clearances
- Product codes: GEX (27), HQF (2), HLJ (1)
- Predicates its devices cite: 24 (12 its own); citations of its devices by later devices: 69 (12 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
- American Dental Technologies, Inc.: 3 (https://510kreport.com/company/american-dental-technologies)
- Star Medical Technologies, Inc.: 2 (https://510kreport.com/company/star-medical-technologies)
- Premier Laser Systems, Inc.: 2 (https://510kreport.com/company/premier-laser-systems)
- Hogan & Hartson: 1 (https://510kreport.com/company/hogan-hartson)
- Coherent Medical Group: 1 (https://510kreport.com/company/coherent-medical-group)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Iriderm Div.: 1 (https://510kreport.com/company/iriderm-div)
- Continuum Biomedical, Inc.: 1 (https://510kreport.com/company/continuum-biomedical)

## Firms that cite its devices most
- Biolitec Medical Devices, Inc.: 9 (https://510kreport.com/company/biolitec-medical-devices)
- Biolitec, Inc.: 8 (https://510kreport.com/company/biolitec)
- Med-Fibers, Inc.: 5 (https://510kreport.com/company/med-fibers)
- Fiberoptic Fabrications, Inc.: 5 (https://510kreport.com/company/fiberoptic-fabrications)
- Msq (M2), Ltd.: 4 (https://510kreport.com/company/msq-m2)
- Sirona Dental Systems GmbH: 4 (https://510kreport.com/company/sirona-dental-systems)
- Fibertech GmbH: 4 (https://510kreport.com/company/fibertech)
- Iridex Corp: 4 (https://510kreport.com/company/iridex)

## Its most-cited devices
- K943445: Megabeam Fiber Optic Delivery System (1994), cited by 10
- K983058: Ceralas D Laser System, Model # Ceralas D15 (1998), cited by 6
- K991891: Ceralas Diode Laser System, Model Ceralas D15 (1999), cited by 5
- K923953: Megabeam (1992), cited by 5
- K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15 (2000), cited by 4
- K951775: Ceralas Diode Laser System (Model Ceralas D50) (1995), cited by 4

## Recent decisions
- K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15 (Oct 2, 2000)
- K001975: Ceralas D10 810NM Laser, Model Ceralas D10-60 (Aug 4, 2000)
- K993911: Ceralas D Diode Laser System, Model D15, D25,D50 (Feb 1, 2000)
- K993828: Ceralas D10 810NM Diode Laser (Feb 1, 2000)
- K993002: Ceralas D 980NM Diode Laser System, Model D15 (Oct 14, 1999)
- K992773: Ceralas D10 810NM Diode Laser (Sep 1, 1999)
- K991891: Ceralas Diode Laser System, Model Ceralas D15 (Jun 24, 1999)
- K983950: Ceralas Diode Laser System (Model H) (Feb 3, 1999)

Source page: https://510kreport.com/company/ceram-optec