510(k) K220877
- Device
- Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
- Applicant
- Lumenis Be, Inc.
- 510(k) number
- K220877
- Product code
- HQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-15
- Date received
- 2022-03-25
- Regulation
- 886.4390
- Classification name
- Laser, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Shlomit Segman
- Address
- 1870 S Milestone Dr. Salt Lake City UT US 84104 84104
FDA Registration Numbers#
- 8043792
- 1000391004
- 3020611964
- 1932180
- 3038356864
- 3013515803
- 1047843
- 8030392
- 3010487482
- 1526711
- 9681121
- 3012037425
- 1222616
- 1928237
- 3008252121
- 1920664
- 1644019
- 3002807090
- 3007589150
- 1054713
- 3002808022
- 3009298127
- 9680671
- 3004858034
- 9615030
- 3005350457
- 3027683457
- 2936921
- 3001592626
- 9611516
- 2028159
- 1211998
- 1018470
- 9615745
- 3008156177
- 3016405041
- 3016678045
- 8030988
- 3002807715
- 1650907
- 2246552
- 2247224
- 3009026057
- 3004467263
- 3004497289
- 3005941719
- 3010208880
- 2529392
- 3015658550
- 1313525
- 3030860039
- 3029221947
- 3002991496
- 3010220595
- 2939653
- 3009337401
- 3010849408
- 3005012805
- 2031962
- 3007851054
- 3009462521
Source Documents#
Other 510(k) Records For Product Code HQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026-04-07 |
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | 2025-06-18 |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025-04-03 |
| K242397 | LYNX Photocoagulator | Norlase Aps | 2024-10-25 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024-09-06 |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | 2024-01-25 |
| K230722 | Eagle device | Belkin Vision, Ltd. | 2023-12-08 |
| K232051 | VISULAS green | Carl Zeiss Meditec | 2023-10-24 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | 2023-09-12 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | 2023-02-23 |
| K220974 | R:GEN | Lutronic Vision, Inc. | 2022-12-27 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022-11-09 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases