APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
FDA 510(k) clearance K082031 · decided 2008-07-31
Clearance details
- K-number
- K082031
- Device name
- APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
- Applicant
- Appasamy Associates
- Decision
- Substantially Equivalent
- Date received
- 2008-07-17
- Decision date
- 2008-07-31
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Arumbakkam, Chennai, IN
- Third-party review
- Yes
- 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.
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| IOLMaster 700 (K173771) | Carl Zeiss Meditec, AG | 2018-08-24 |
| SLM-1ER, SLM-2ER, SLM-3ER (K171877) | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 |
| Digital Eye Anterior Camera (K170470) | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 |
| Portable Slit Lamp Microscope (K162778) | Suzhou Kangjie Medical, Inc. | 2017-07-21 |
| SL 220 (K162684) | Carl Zeiss Meditec, AG | 2017-05-31 |
| SLIT LAMP SL-2000 (K163564) | Nidek Co., Ltd. | 2017-05-19 |
| Marco Ultra M3, Marco Ultra M4 (K162636) | Takagi Seiko Co., Ltd. | 2017-04-14 |
Recalls involving this device
No recalls on record reference this clearance.