BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
FDA 510(k) clearance K024289 · decided 2003-05-02
Clearance details
- K-number
- K024289
- Device name
- BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
- Applicant
- Bausch & Lomb, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-05-02
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bausch & Lomb
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080021) | Bausch & Lomb, Incorporated | 2009-02-02 |