FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-25 KRYPTON ION LASER (SURGICA K5)
K Number: K930543
·
Decision Jun 22, 1993
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
23
Review Days
140
Basic Information
- Device Name
- E-25 KRYPTON ION LASER (SURGICA K5)
- K Number
- K930543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HGM, INC.
- Date Received
- February 2, 1993
- Decision Date
- June 22, 1993
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by HGM, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K950120 | SMART PLUG | Aug 11, 1995 | Substantially Equivalent |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Nov 10, 1994 | Substantially Equivalent |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | Mar 1, 1994 | Substantially Equivalent |
| K933333 | HGM SCANMAN PLUS | Sep 23, 1993 | Substantially Equivalent |
| K931499 | Q-11 OPHTHALMIC LASER | Aug 19, 1993 | Substantially Equivalent |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | Aug 17, 1993 | Substantially Equivalent |
| K880908 | MODEL PC ARGON LASER | May 3, 1988 | Substantially Equivalent |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | Oct 13, 1987 | Substantially Equivalent |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Aug 25, 1987 | Substantially Equivalent |
| K870773 | ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER | Jul 10, 1987 | Substantially Equivalent |