The following data is part of a premarket notification filed by Lambda Scientific Spa with the FDA for Doctor Smile A-810 And B-980 Lasers.
| Device ID | K091562 |
| 510k Number | K091562 |
| Device Name: | DOCTOR SMILE A-810 AND B-980 LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LAMBDA SCIENTIFIC SPA VIA RETRONE 39 Altavilla Vicentina, Vicenza, IT 36077 |
| Contact | Boschi Alessandro |
| Correspondent | Boschi Alessandro LAMBDA SCIENTIFIC SPA VIA RETRONE 39 Altavilla Vicentina, Vicenza, IT 36077 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-28 |
| Decision Date | 2009-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056093611120 | K091562 | 000 |
| 08056093611083 | K091562 | 000 |
| 08056093611076 | K091562 | 000 |
| 08056093611069 | K091562 | 000 |
| 08056093611052 | K091562 | 000 |
| 08056093610093 | K091562 | 000 |
| 08056093610062 | K091562 | 000 |
| 08056093611137 | K091562 | 000 |