Data / Medical devices / Russia / Medical Laser Technologies Ltd.
Medical Laser Technologies Ltd.: FDA-registered device maker in ZELENOGRAD Moskva, Russia, 2 510(k) clearances
Medical Laser Technologies Ltd. is registered with the FDA (registration 3004529369) in ZELENOGRAD Moskva, Russia. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 17, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004529369
- Address
- 4 Zapadny Proezd, Building 4, ZELENOGRAD Moskva, Russia, 103460
- Owner or operator
- AEROLASE CORPORATION (9047647)
- Roles
- Manufacturer
- First device listed
- August 27, 2021
- Registered through
- 2026
- Brand names listed
- Era Elite, LightPod Era, LightPod Neo, Neo Elite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2012 | K120235 | MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP | GEX | Substantially Equivalent | Aerolase Medical Lasers, LLC | accessdata.fda.gov |
| November 6, 2000 | K000023 | FRIENDLY LIGHT ER:YAG PULSED LASER | GEX | Substantially Equivalent | Innotech USA, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 17, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.