FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 930 ARGON PHOTOCOAGULATOR
K Number: K844356
·
Decision May 16, 1985
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
27
Review Days
188
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Basic Information
- Device Name
- SYSTEM 930 ARGON PHOTOCOAGULATOR
- K Number
- K844356
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Coherent Medical Group
- Date Received
- November 9, 1984
- Decision Date
- May 16, 1985
- Product Code
- HQB
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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Other Clearances by Coherent Medical Group
| K Number | Device Name | ||
|---|---|---|---|
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Jan 22, 1997 | Substantially Equivalent |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | Apr 1, 1996 | Substantially Equivalent |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | May 2, 1994 | Substantially Equivalent |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Sep 29, 1993 | Substantially Equivalent |
| K932468 | NOVUS MULTIWAVELENGTH | Sep 22, 1993 | Substantially Equivalent |
| K930981 | ACCULITE(TM) OTOPROBE | Jul 28, 1993 | Substantially Equivalent |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Jul 21, 1992 | Substantially Equivalent |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | May 6, 1992 | Substantially Equivalent |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Oct 8, 1991 | Substantially Equivalent |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Sep 25, 1991 | Substantially Equivalent |