PMA P020050S032
- Device
- ALLEGRO Topolyzer VARIO and Patient Bed Swivel
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S032
- Product code
- LZS
- Decision date
- 2019-03-14
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval for a change in labeling to align with the labeling recommendations of IEC 60601-1-2:2014 (4th edition).
Current openFDA PMA Record#
- Device
- ALLEGRO Topolyzer VARIO and Patient Bed Swivel
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S032
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2019-03-14
- Decision code
- APPR
- Date received
- 2019-02-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in labeling to align with the labeling recommendations of IEC 60601-1-2:2014 (4th edition).