FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
K Number: K012821
·
Decision Oct 22, 2001
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
10
Review Days
60
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Basic Information
- Device Name
- D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- K Number
- K012821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dutch Ophthalmic USA, Inc.
- Date Received
- August 23, 2001
- Decision Date
- October 22, 2001
- Product Code
- HRN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Dutch Ophthalmic USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010082 | D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM | Mar 12, 2001 | Substantially Equivalent |
| K983797 | D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM | Mar 3, 1999 | Substantially Equivalent |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | May 20, 1998 | Substantially Equivalent |
| K973229 | D.O.R.C. HEXON ILLUMINATION SYSTEM | Nov 25, 1997 | Substantially Equivalent |
| K973757 | D.O.R.C. SOLUX LIGHT SOURCE | Nov 7, 1997 | Substantially Equivalent |
| K962135 | D.O.R.C. MICRODIATHERMY SYSTEM | Aug 29, 1996 | Substantially Equivalent |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | Apr 15, 1996 | Substantially Equivalent |
| K940373 | OPHTHALMIC CRYO UNIT | Jul 18, 1994 | Substantially Equivalent |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Jun 26, 1990 | Substantially Equivalent |