The following data is part of a premarket notification filed by Curelight Ltd with the FDA for Reclear Phototherapy System, Model Fgcm0012.
| Device ID | K033183 |
| 510k Number | K033183 |
| Device Name: | RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CURELIGHT LTD 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CURELIGHT LTD 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2004-04-15 |
| Summary: | summary |