FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACMI DUR-HL LASER SYSTEMS
K Number: K060752
·
Decision May 25, 2006
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
16
Review Days
65
Basic Information
- Device Name
- ACMI DUR-HL LASER SYSTEMS
- K Number
- K060752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACMI CORPORATION
- Date Received
- March 21, 2006
- Decision Date
- May 25, 2006
- 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 ACMI CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K061975 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK | Aug 10, 2006 | Substantially Equivalent |
| K060269 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM | Mar 31, 2006 | Substantially Equivalent |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Sep 2, 2005 | Substantially Equivalent |
| K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | Aug 16, 2005 | Substantially Equivalent |
| K043581 | DUAL LUMEN CATHETER | Mar 3, 2005 | Substantially Equivalent |
| K042069 | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM | Nov 1, 2004 | Substantially Equivalent |
| K042225 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | Sep 10, 2004 | Substantially Equivalent |
| K031758 | ACMI M4 TELESCOPES | Sep 2, 2003 | Substantially Equivalent |
| K030960 | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE | Jul 16, 2003 | Substantially Equivalent |
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Jun 23, 2003 | Substantially Equivalent |