The following data is part of a premarket notification filed by Aerolase Medical Lasers Llc with the FDA for Model Family Of Aerolase Nd:yag Lasers: Friendlylight Nd: Yag Lasers, Friendlylight Neo, Lightpod Nd: Yag Lasers, Lightp.
| Device ID | K120235 |
| 510k Number | K120235 |
| Device Name: | MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AEROLASE MEDICAL LASERS LLC 555 THIRTEENTH STREET Washington, DC 20004 |
| Contact | Jennifer A Henderson |
| Correspondent | Jennifer A Henderson AEROLASE MEDICAL LASERS LLC 555 THIRTEENTH STREET Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-25 |
| Decision Date | 2012-09-17 |
| Summary: | summary |