Product areas
FDA product code distribution
Candela Corporation
Country / region:United States (US)
510(k) submissions
7 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | GEX | Class 2 | 2023-06-01 |
| K220853 | PicoWay Laser System | GEX | Class 2 | 2022-10-13 |
| K212492 | Frax 1940 for Nordlys and Frax Pro | GEX | Class 2 | 2021-12-20 |
| K201111 | GentleMax Pro Plus | GEX | Class 2 | 2020-05-26 |
| K191685 | PicoWay Laser System | GEX | Class 2 | 2019-09-16 |
| K183452 | Vbeam Prima Laser System | GEX | Class 2 | 2019-02-01 |
| K150326 | PicoWay Laser System | GEX | Class 2 | 2015-04-16 |
Company profile
- Canonical name
- Candela Corporation
- Aliases
- Candela Corp.
- Country
- United States(US)
Cited predicates
28- K183452
—
—
Not ingested - K050673
—
—
Not ingested - K191685
—
—
Not ingested - K130193
—
—
Not ingested - K192951
—
—
Not ingested - K140122
—
—
Not ingested - K170597
PicoWay Laser System
- K172077
Cutera enlighten III Laser System
- K162454
PicoWay Laser System
- K160607
PicoWay Laser System
- K160480
PicoSure Workstation
- K150326
PicoWay Laser System
- K142372
—
—
Not ingested - K153527
PicoWay Laser System
- K180593
—
—
Not ingested - K140122
—
—
Not ingested - K142372
Pico Way Laser System
—
- K140727
CUTERA PICOSECOND LASER SYSTEM
—
- K133945
CUTERA PICOSECOND LASER SYSTEM
—
- K133283
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
—
- K133254
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
—
- K132185
FAMILY OF COOLGLIDE AESTHETIC LASERS
—
- K121346
PICOSURE WORKSTATION
—
- K120510
—
—
Not ingested - K103539
QUANTA SYSTEM DUOLITE
—
- K103118
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
—
- K083889
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
—
- K081324
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
—
Candela Corporation references 28 predicate/reference devices
Cited as predicate
22- K261094
YellowStar
- K252877
SANDRO Dual
Not ingested - K251981
Boston PICO (Boston PICO)
- K242534
HandPICO Fractional Laser Handpiece Tip
- K241407
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Not ingested - K240386
Picosecond Nd:YAG Laser Systems (BL-C10)
Shanghai Bele Medical Technology Co.,Ltd
Not ingested - K233757
TitanPico Laser Workstation (PICO-450)
Rhein Laser Technologies Co., Ltd.
Not ingested - K230990
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
Not ingested - K230373
HELIOS 785 Pico
- K223540
AvalancheLase Family
- K222673
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
Not ingested - K220853
PicoWay Laser System
Not ingested - K212790
XLase Plus
- K202172
StarWalker
Not ingested - K201773
PICOHI
Not ingested - K200116
PicoSecond Nd: YAG Laser System
Shanghai Apolo Medical Technology Co., Ltd.
Not ingested - K191685
PicoWay Laser System
- K170597
PicoWay Laser System
- K162454
PicoWay Laser System
- K160607
PicoWay Laser System
Not ingested - K153527
PicoWay Laser System
Not ingested - K152012
EVO platform
22 submissions cite Candela Corporation as a predicate