CERALAS I LASER
FDA premarket approval P050021 · decided 2005-12-20
Approval details
- PMA number
- P050021
- Trade name
- CERALAS I LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Biolitec, Inc.
- Date received
- 2005-06-09
- Decision date
- 2005-12-20
- Days to decision
- 194 days
- Decision code
- APWD
- Product code
- MVF
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- East Longmeadow, MA
- Statement
- APPROVAL FOR THE CERALAS I LASER SYSTEM AND CERALINK SLIT LAMP ADAPTER. THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HISTOPLASMOSIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER (K112013) | Biolitec, Inc. | 2012-01-13 |
| CERALAS 147NM DIODE LASER SYSTEM (K112253) | Biolitec, Inc. | 2011-09-20 |
| RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM (K110080) | Biolitec, Inc. | 2011-02-24 |
| CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER (K102755) | Biolitec, Inc. | 2010-12-16 |
| ENDOVASCULAR LAER VEIN SYSTEM KIT (K101712) | Biolitec, Inc. | 2010-10-27 |
| CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM (K100726) | Biolitec, Inc. | 2010-09-15 |
| CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER (K090164) | Biolitec, Inc. | 2009-06-26 |
| 180W CERELAS D 980NM DIODE LASER, MODEL D180 (K083682) | Biolitec, Inc. | 2009-01-09 |