The following data is part of a premarket notification filed by Eclipse Aesthetics, Llc with the FDA for E-beam Nd: Yag Laser.
| Device ID | K122922 |
| 510k Number | K122922 |
| Device Name: | E-BEAM ND: YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ECLIPSE AESTHETICS, LLC 13998 DIPLOMAT DRIVE Dallas, TX 75234 |
| Contact | Tom Obrien |
| Correspondent | Tom Obrien ECLIPSE AESTHETICS, LLC 13998 DIPLOMAT DRIVE Dallas, TX 75234 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800020102027 | K122922 | 000 |
| 08800020102010 | K122922 | 000 |