AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
FDA 510(k) clearance K132042 · decided 2014-04-28
Clearance details
- K-number
- K132042
- Device name
- AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
- Applicant
- X6d, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-02
- Decision date
- 2014-04-28
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- HOY
- Device class
- 1
- Regulation number
- 886.4750
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Zur- Moshe, IL
- 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 |
|---|---|---|
| LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (K050856) | Ophthocare , Ltd. | 2005-05-31 |
| NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (K971465) | National Healthcare Mfg. Corp. | 1997-06-04 |
| ARCTIC PREMIER SERIES (K944700) | Sungold Eyewear, Inc. | 1994-12-22 |
| GOGGLE SAFEGUARD (K944857) | Sellstrom Mfg. Co. | 1994-12-15 |
| SHIELD, EYE, OPHTHALMIC (K945351) | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| MAKROLON 2405 GOGGLES (LIGHT AND DARK) (K945346) | Universal Massage & Tanning, Inc. | 1994-11-22 |
| AMCON SLIP IN MYDRIATIC SUNGLASSES (K942407) | Amcon Laboratories, Inc. | 1994-06-06 |
| SUN FILTERS/SHIELDS (K941829) | Klinger Eye Shields, Inc. | 1994-05-17 |
| SHAIDS PROTECTIVE GLASSES (K930347) | Depuy, Inc. | 1994-04-29 |
| UNIVERSAL CUSHIONED METAL EYE SHIELD (K940213) | P.J. Products, Inc. | 1994-03-24 |
| UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD (K940275) | P.J. Products, Inc. | 1994-03-24 |
| POST-MYDS(TM) (K930840) | Aukland Medical Plastics, Inc. | 1994-03-01 |
Recalls involving this device
No recalls on record reference this clearance.