FDA.reportPublic FDA data

ROHRER AESTHETICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30319449513031944951ROHRER AESTHETICS, INC.1Y2026-01-01121 Citation Ct Homewood AL US 35209

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3295091710051593K251919Thulium Laser System (Deluxlase)GEX2025-09-26
3295091504435544K233307Intensity Pulsed Light Therapy SystemONF2024-03-15
3295091627074428K233147PiXel8-RFGEI2023-10-25
3295091042244256K233143PiXel8-RevealGEX2024-02-02
3295091884888045K233099GladiatorGEI2024-05-22
3295091327319646K210535UltraLight LED SystemGEX2021-05-24
3295091740557800K192583PicoLazer Laser SystemGEX2020-01-17
3295091624274941K191162EpiLaze Multi-wavelength LaserGEX2019-07-09
3295091864338804K191068Powersculp laser lipolysis systemPKT2019-07-17
3295091478344875K180654PINXEL-RF systemGEI2018-07-13
3295091906300351K123777MULTILASER SYSTEMGEX2013-04-11
3295091857148066K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMGEX2012-12-14
3295091191615920K110434TRIXEL CO2 LASERGEX2011-04-19
3295092059726305K102524FUTURAIMG2011-11-03
3295091698483727K042496ADEPT ULTRALITE 532 LASERGEX2004-11-02
3295091397179436
3295091914633895

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX92025-09-26
GEI32024-05-22
ONF12024-03-15
PKT12019-07-17
IMG12011-11-03