510(k) K240615
- Device
- Leos Laser and Endoscopy System
- Applicant
- Beaver-Visitec International, Inc.
- 510(k) number
- K240615
- Product code
- HQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-03
- Date received
- 2024-03-05
- 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
- N
Related Records
Applicant Contact
- Contact
- Christopher Brady
- Address
- 10 Citypoint 500 Totten Pond Rd. Waltham MA US 02451 02451
FDA Registration Numbers
- 3002807090
- 3008156177
- 3010220595
- 8030988
- 3010208880
- 3010487482
- 3012037425
- 2936921
- 1054713
- 3001592626
- 3008252121
- 2028159
- 3005941719
- 3020611964
- 2939653
- 3002808022
- 1018470
- 3009298127
- 9611516
- 3016678045
- 1932180
- 3004858034
- 1526711
- 2031962
- 3029221947
- 3027683457
- 3002807715
- 1313525
- 1644019
- 3005012805
- 3015658550
- 1211998
- 1047843
- 3009026057
- 3016405041
- 3007851054
- 3005350457
- 1920664
- 2529392
- 3007589150
- 3013515803
- 3009337401
- 9680671
- 2246552
- 8043792
- 1650907
- 3030860039
- 3004467263
- 8030392
- 9615745
- 1928237
- 3009462521
- 2247224
- 1000391004
- 3010849408
- 3004497289
- 9615030
- 1222616
- 3038356864
- 3002991496
- 9681121
Source Documents
Other 510(k) Records For Product Code HQF
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|---|---|---|---|
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| 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 |
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