Femtosecond Laser System For Refractive Correction

Product Code: OTL

Medical Laser Products

Definition: Ophthalmic Femtosecond Laser Intended To Provide Refractive Vision Correction By Modification Of The Shape Of The Cornea.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations:

• Radiation Type: Optical
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as OTL

4451

Femtosecond Laser System For Refractive Correction

Total Product Life Cycle (TPLC) Devices

4451

Femtosecond Laser System For Refractive Correction

Pre-market Approvals for OTL

P150040

VisuMax Femtosecond Laser System

Carl Zeiss Meditec, Inc.

Global Unique Device Identification Database

• 04049471095111: Femtosecond Laser System For Refractive Correction

Maude Adverse Events

VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2020-02-20
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2019-07-12
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2019-06-27
RE-LEX SMILE	CARL ZEISS MEDITEC AG (JENA)	2019-05-07
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2019-03-14
RELEX SMILE	UNKNOWN	2019-03-07
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2018-12-21
VISUMAX FEMTOSECOND LASER	CARL ZEISS MEDITEC AG (JENA)	2018-12-07
VISUMAX FEMTOSECOND LASER (SMILE)	CARL ZEISS MEDITEC AG (JENA)	2018-11-26
VISUMAX FEMTOSECOND LASER (SMILE)	CARL ZEISS MEDITEC AG (JENA)	2018-11-26
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2018-11-01
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2018-10-28
ZEISS LASER	CARL ZEISS MEDITEC INC.	2018-09-18
SMILE	CARL ZEISS MEDITEC AG	2018-09-17
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2018-09-11
FEMTOSECOND LASER (SMILE)	CARL ZEISS MEDITEC	2018-07-31
RELEX SMILE	CARL ZEISS	2018-05-09
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2018-01-18
OPHTHALMIC FEMTOSECOND LASER	UNK	2018-01-16
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-11-03
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-11-03
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-08-23
RELEX SMILE APPARATUS	UNK	2017-08-09
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-07-28
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-06-15
VISUMAX FEMTOSECOND LASER	CARL ZEISS MEDITEC, INC.	2017-04-06
VISUMAX LASER KERATOME	CARL ZEISS MEDITEC AG (JENA)	2017-03-11
VISUMAX FEMTOSECOND LASER	CARL ZEISS	2016-10-12