The following data is part of a premarket notification filed by Lambda S.p.a. with the FDA for Doctor Surgery Diode Lasers Family.
| Device ID | K102036 |
| 510k Number | K102036 |
| Device Name: | DOCTOR SURGERY DIODE LASERS FAMILY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LAMBDA S.P.A. VIA DEL'IMPRESA 1 Brendola, Vicenza, IT 36040 |
| Contact | Boschi Alessandro |
| Correspondent | Boschi Alessandro LAMBDA S.P.A. VIA DEL'IMPRESA 1 Brendola, Vicenza, IT 36040 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18056093611110 | K102036 | 000 |
| 18056093611042 | K102036 | 000 |
| 18056093611035 | K102036 | 000 |
| 18056093611028 | K102036 | 000 |
| 18056093611011 | K102036 | 000 |
| 08056093610109 | K102036 | 000 |
| 08056093610024 | K102036 | 000 |
| 08056093611007 | K102036 | 000 |
| 08056093610284 | K102036 | 000 |