NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
FDA 510(k) clearance K040913 · decided 2004-07-23
Clearance details
- K-number
- K040913
- Device name
- NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
- Applicant
- Bausch & Lomb
- Decision
- Substantially Equivalent
- Date received
- 2004-04-08
- Decision date
- 2004-07-23
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MXK
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Dimas, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADATO SIL-OL 5000 Silicone Oils (P910071/S019) | Bausch & Lomb | 2025-12-22 |
| Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (P860022/S061) | Bausch & Lomb | 2025-12-16 |
| Boston Orthokeratology (oprifocon A) (P010062/S015) | Bausch & Lomb | 2025-12-16 |
| Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S014) | Bausch & Lomb | 2025-02-20 |
| Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl (P860022/S060) | Bausch & Lomb | 2024-07-18 |
| Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S013) | Bausch & Lomb | 2024-07-18 |
| Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL) (P910061/S027) | Bausch & Lomb | 2022-01-19 |
| ADATO Sil-Ol 5000 Silicone Oil (P910071/S018) | Bausch & Lomb | 2021-12-02 |