POWER LED 175
FDA 510(k) clearance K123956 · decided 2013-01-25
Clearance details
- K-number
- K123956
- Device name
- POWER LED 175
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-21
- Decision date
- 2013-01-25
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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| ACUEITY MEDICAL LIGHT SOURCE (K032430) | Acueity, Inc. | 2003-09-05 |
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| COLDLIGHTSOURCE PL3000 (K993300) | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| 50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447) | Angiolaz, Inc. | 1999-10-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |