FORMALENS 2000
FDA 510(k) clearance K863367 · decided 1986-09-26
Clearance details
- K-number
- K863367
- Device name
- FORMALENS 2000
- Applicant
- Vision-Sciences, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-09-03
- Decision date
- 1986-09-26
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- HQG
- Device class
- 1
- Regulation number
- 886.5844
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Monrovia, CA, 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 |
|---|---|---|
| SUNGLASSES (K935919) | Ja-Ru, Inc. | 1994-02-16 |
| 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795) | Optical Radiation Corp. | 1992-07-13 |
| MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR (K900091) | Onufryk Low Vision Ent. | 1990-04-04 |
| SEIKO P-6 PROGRESSIVE SPECTACLE LENSES (K884360) | Seiko Corp. | 1988-11-15 |
| NEOLENS PRESCRIPTION SPECTACLE LENS (K882814) | Neolens, Inc. | 1988-07-29 |
| CR-39 PLASTIC LENSES FOR EYEGLASSES (K882308) | Automated Lens System | 1988-07-22 |
| OPHTHALMIC SPECTACLE LENS BLANKS (K881225) | Beta Optical Co, Inc. | 1988-04-19 |
| SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. (K875063) | Epson EL Paso, Inc. | 1988-02-22 |
| SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES (K874681) | Klockner Contract Packaging, Inc. | 1988-02-05 |
| AR DIACOAT SINGLE VISION LENSES (K873245) | Seiko Optical Products of America, Inc. | 1987-10-05 |
| MELANITE I (K872506) | Aura Lens Products | 1987-07-27 |
| MULTIPLE SPECTACLE LENS (K871961) | Korea Asahi Optical Co., Ltd. | 1987-06-03 |
Recalls involving this device
No recalls on record reference this clearance.