FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K Number: K910805
·
Decision May 24, 1991
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
38
Review Days
87
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Basic Information
- Device Name
- ND:YAG LASER SYSTEMS (VARIOUS MODELS)
- K Number
- K910805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Lasersonics, Inc.
- Date Received
- February 26, 1991
- Decision Date
- May 24, 1991
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Heraeus Lasersonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | Apr 21, 1994 | Substantially Equivalent |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | Nov 25, 1992 | Substantially Equivalent |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Jun 18, 1992 | Substantially Equivalent |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Jun 15, 1992 | Substantially Equivalent |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | Mar 27, 1992 | Substantially Equivalent |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | Feb 27, 1992 | Substantially Equivalent |
| K913887 | C02 LASER WAVEGUIDE | Dec 9, 1991 | Substantially Equivalent |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | Oct 31, 1991 | Substantially Equivalent |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | Sep 25, 1991 | Substantially Equivalent |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | Sep 16, 1991 | Substantially Equivalent |