The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Spectra Laser System.
| Device ID | K113588 |
| 510k Number | K113588 |
| Device Name: | SPECTRA LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447654751 | K113588 | 000 |
| 08809447654768 | K113588 | 000 |
| 08809447654782 | K113588 | 000 |
| 08809447654799 | K113588 | 000 |
| 08809447654690 | K113588 | 000 |
| 08809447654805 | K113588 | 000 |
| 08809447654713 | K113588 | 000 |
| 08809447654720 | K113588 | 000 |
| 08809447654737 | K113588 | 000 |
| 08809447654744 | K113588 | 000 |
| 08809447654775 | K113588 | 000 |