Kowa SL-19
510(k) K222372
Kowa SL-19 is a medical device (FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Kowa Company, Ltd., cleared under FDA 510(k) K222372 on 21 Nov 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222372 | Date21 Nov 2022 | StatusActive |
Official records
- FDA 510(k) database K222372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HJO
- FDA applicant
- Kowa Company , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K222372
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| KOWA SL-19 SL191BK/W | SL191BK/W | 04987646810223 | Weight 620 g; Width 107 mm; Depth 197 mm; Height 238 mm | On the market |
| KOWA SL-19 SL191K/A | SL191K/A | 04987646810049 | Weight 620 g; Width 107 mm; Depth 197 mm; Height 238 mm | On the market |
| KOWA SL-19 SL191K/B | SL191K/B | 04987646810070 | Weight 620 g; Width 107 mm; Depth 197 mm; Height 238 mm | On the market |
| KOWA SL-19 SL191K/G | SL191K/G | 04987646810056 | Weight 620 g; Width 107 mm; Depth 197 mm; Height 238 mm | On the market |
| KOWA SL-19 SL191K/P | SL191K/P | 04987646810063 | Width 107 mm; Depth 197 mm; Height 238 mm; Weight 620 g | On the market |
| KOWA SL-19 SL191K/W | SL191K/W | 04987646810032 | Weight 620 g; Width 107 mm; Depth 197 mm; Height 238 mm | On the market |
| KOWA SL-19 SL192BK/W | SL192BK/W | 04987646810476 | Weight 730 g; Width 107 mm; Depth 197 mm; Height 255 mm | On the market |
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