ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
FDA 510(k) clearance K936198 · decided 1994-04-06
Clearance details
- K-number
- K936198
- Device name
- ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-29
- Decision date
- 1994-04-06
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- GCT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Thornwood, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALPHAXENON LIGHT 180 W AND 300 W (K093125) | Gimmi GmbH | 2010-01-27 |
| XENON-100 SCB LIGHT SOURCE, MODEL 20132620 (K082925) | KARL STORZ Endoscopy-America, Inc. | 2008-12-18 |
| CONMED LINVATEC 300W XENON LIGHT SOURCE (K070376) | Conmed Linvatec | 2007-08-20 |
| VIADUCT MINISCOPE AND ACCESSORIES (K040949) | Acueity, Inc. | 2004-05-07 |
| KSEA MEDI PACK (K022490) | KARL STORZ Endoscopy-America, Inc. | 2003-09-29 |
| LINVATEC 300W XENON LIGHT SOURCE (K031994) | Linvatec Corp. | 2003-08-21 |
| ENDOSCOPIC LIGHT SOURCE XL180/L3 (K023468) | World of Medicine Lemke GmbH | 2003-01-14 |
| ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (K021717) | World of Medicine Lemke GmbH | 2002-08-20 |
| ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889) | World of Medicine Lemke GmbH | 2002-06-05 |
| DAYLITE XENON LIGHT SOURCES (K013880) | Designs For Vision, Inc. | 2001-12-07 |
| LUMENON XENON LIGHT SOURCE (K992050) | Walter Lorenz Surgical, Inc. | 1999-09-14 |
| XENON LIGHT SOURCE PES 1 (K992540) | Laser Optik Systeme GmbH & Co. KG | 1999-09-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |