510(k) K220974
- Device
- R:GEN
- Applicant
- Lutronic Vision, Inc.
- 510(k) number
- K220974
- Product code
- HQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-27
- Date received
- 2022-04-04
- 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
Related Records
Applicant Contact
- Contact
- Haelyung Hwang
- Address
- 19 Fortune Dr. Billerica MA US 01821 01821
FDA Registration Numbers
- 1018470
- 1222616
- 3002807715
- 2529392
- 3004467263
- 3004497289
- 3016678045
- 1644019
- 3005350457
- 8043792
- 3002807090
- 3010208880
- 3038356864
- 1054713
- 2247224
- 3010220595
- 1920664
- 3029221947
- 9681121
- 2246552
- 3010849408
- 3027683457
- 9615030
- 3012037425
- 3002808022
- 2031962
- 8030392
- 3007851054
- 3010487482
- 1313525
- 3008252121
- 2028159
- 3030860039
- 2939653
- 9611516
- 3009462521
- 3004858034
- 3015658550
- 3009298127
- 3007589150
- 3008156177
- 3005941719
- 1211998
- 2936921
- 1047843
- 3009337401
- 1000391004
- 3013515803
- 3016405041
- 1932180
- 3002991496
- 9680671
- 3009026057
- 1526711
- 1928237
- 9615745
- 3005012805
- 3020611964
- 8030988
- 1650907
- 3001592626
Source Documents
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