Kowa Sl-17
510(k) K133755
Kowa Sl-17 is a medical device (FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Kowa Co., Ltd., cleared under FDA 510(k) K133755 on 11 Mar 2014, 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 | NumberK133755 | Date11 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133755
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HJO
- FDA applicant
- Kowa Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K133755
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-17 SL170K/A | SL170K/A | 04987646806912 | Height 220 mm; Depth 95 mm; Width 220 mm; Weight 745 g | On the market |
| KOWA SL-17 SL170K/G | SL170K/G | 04987646806929 | Height 220 mm; Depth 95 mm; Width 220 mm; Weight 745 g | On the market |
| KOWA SL-17 SL170K/P | SL170K/P | 04987646806936 | Height 220 mm; Depth 95 mm; Width 220 mm; Weight 745 g | On the market |
| KOWA SL-17 SL170K/W | SL170K/W | 04987646806905 | Width 220 mm; Weight 745 g; Height 220 mm; Depth 95 mm | On the market |
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