← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K030891
# SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK (K030891)
_Surgistar, Inc. · HNO · Jun 17, 2003 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K030891
## Device Facts
- **Applicant:** Surgistar, Inc.
- **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md)
- **Decision Date:** Jun 17, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4370
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic
## Intended Use
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea. The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
## Device Story
Surgistar microkeratome blades (models 2400-LSK, 2410-CB, 2420-M2) are single-use, disposable replacement blades for Moria microkeratome systems. Each device consists of a 420 low carbon stainless steel blade attached to a plastic holder. Used by ophthalmic surgeons in clinical settings during corneal surgery to perform initial lamellar resection. The blades function as the cutting component within the existing Moria microkeratome head. By providing a sharp, sterile, disposable cutting edge, the device facilitates the creation of corneal flaps or lamellar sections required for refractive procedures. The surgeon installs the blade into the compatible Moria keratome head prior to the procedure; the device's performance is dependent on the mechanical operation of the host keratome system.
## Clinical Evidence
No clinical data. Evidence consists of bench testing and non-clinical porcine eye studies. Bench testing included dimensional equivalency measurements, sharpness testing, and mechanical fit testing with the respective Moria keratome heads. Porcine eye studies demonstrated that the Surgistar blades produced corneal lamellar sections equivalent to those produced by the predicate Moria blades.
## Technological Characteristics
Materials: 420 low carbon stainless steel blade, plastic holder. Energy source: Mechanical (manual/motorized operation via host keratome). Connectivity: None. Sterilization: Gamma irradiation (2400-LSK) or ETO (2410-CB, 2420-M2). Form factor: Disposable, single-use replacement blade for specific Moria microkeratome heads.
## Regulatory Identification
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
## Predicate Devices
- PLANCON MICROLAMELLAR KERATOME; LSK-1 Keratome ([K970377](/device/K970377.md))
- CARRIAZO BARRAQUER MICROKERATOME ([K981741](/device/K981741.md))
- CARRIAZO BARRAQUER II MICROKERATOME ([K002191](/device/K002191.md))
## Submission Summary (Full Text)
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KO30891
Page 1 of 2
Surgistar, Inc. Replacement Keratome Blades
March 19, 2003 Premarket Notification
JUN 1 7 2003
# 510(K) Summary
# Surgistar 2400-LSK
| Submitter: | Surgistar, Inc.
6068 Corte Del Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (760) 431 6768 |
| Contact person: | Jonathan Woodward |
| Date Prepared: | March 19, 2003 |
| Device Trade Name: | Surgistar Microkeratome Blade,
Model No. 2400-LSK |
| Device Common Name: | Keratome Blade, Microkeratome Blade |
| Device Classification Name: | Keratome (Blade Only) |
| Classification Regulation No.: | CLASS 1, Reserved |
| Classification Panel: | OPHTHALMIC |
| Product Code: | 86 HNO |
Legally marketed device to which we are claiming equivalence:
| Predicate Device Name: | PLANCON MICROLAMELLAR
KERATOME; LSK-1 Keratome (Blade only) |
|------------------------|----------------------------------------------------------------|
| Manufacturer: | PLANCON INSTRUMENTS (Moria, Inc.) |
| 510(k) Number: | K970377 |
#### Description of the Device:
The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK-ONE Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2400-LSK blades are single-use, disposable blades.
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# March 19, 2003 Premarket Notification
Page 2 of 2 Summary
#### Intended use of the device:
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
### Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA LSK-ONE BLADE
(PREDICATE) | SURGISTAR LSK-2400
BLADE |
|----------------------|-------------------------------------------------------|-----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
LSK-ONE Microkeratome. | Same |
| Blade Material | Low Carbon Stainless Steel | Same |
| Biocompatibility | For Stainless Steel Blades | Same |
| Mechanical Safety | Assured | Same |
| Sterilization Method | Gamma Irradiation | Same |
#### Performance tests and conclusions:
- 1. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
- Sharpness Sharpness tests indicate the Surgistar 2400-LSK performs 2. equivalently to the Moria LSK-ONE.
- 3. Keratome Fit Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable.
- 4. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2400-LSK and the Moria LSK-ONE.
- Conclusion The Surgistar 2400-LSK was demonstrated to be substantially ર. equivalent to the predicate Moria LSK-ONE.
(Premarket Notification [510(k)] Number)
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March 19, 2003 Premarket Notification
Page 1 of 2
# 510(K) Summary
# Surgistar 2410-CB
| Submitter: | Surgistar, Inc.
6068 Corte Del Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (760) 431 6768 |
| Contact person: | Jonathan Woodward |
| Date Prepared: | March 19, 2003 |
| Device Trade Name: | Surgistar Microkeratome Blade,
Model No. 2410-CB |
| Device Common Name: | Keratome Blade, Microkeratome Blade |
| Device Classification Name: | Keratome (Blade Only) |
| Classification Regulation No.: | CLASS 1, Reserved |
| Classification Panel: | OPHTHALMIC |
| Product Code: | 86 HNO |
Legally marketed device to which we are claiming equivalence:
| Predicate Device Name: | CARRIAZO BARRAQUER
MICROKERATOME (Blade only) |
|------------------------|--------------------------------------------------|
| Manufacturer: | MORIA, Inc. |
| 510(k) Number: | K981741 |
### Description of the Device:
The Surgistar 2410-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2410-CB blades are single-use, disposable blades.
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Page 2 of 2 Summary
#### Intended use of the device:
The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
#### Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA C-B BLADE
(PREDICATE) | SURGISTAR LSK-2400
BLADE |
|----------------------|---------------------------------------------------------------------|-----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
Carriazo Barraquer
Microkeratome. | Same |
| Blade Material | Low Carbon Stainless Steel | Same |
| Biocompatibility | For Stainless Steel Blades | Same |
| Mechanical Safety | Assured | Same |
| Sterilization Method | ETO | Same |
#### Performance tests and conclusions:
- 1. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
- 2. Sharpness Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade.
- 3. Keratome Fit Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable.
- 4. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade.
- 5. Conclusion The Surgistar 2410-CB was demonstrated to be substantially equivalent to the predicate Moria C-B Microkeratome blade.
(Premarket Notification [510(k)] Number)
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March 19, 2003 Premarket Notification
Page 1 of 2
# 510(K) Summary
## Surgistar 2420-M2
| Submitter: | Surgistar, Inc.
6068 Corte Del Cedro
Carlsbad, CA. 92009 |
|--------------------------------|----------------------------------------------------------------|
| Telephone: | (760) 431-7400
Fax: (760) 431 6768 |
| Contact person: | Jonathan Woodward |
| Date Prepared: | March 19, 2003 |
| Device Trade Name: | Surgistar Microkeratome Blade,
Model No. 2420-M2 |
| Device Common Name: | Keratome Blade, Microkeratome Blade |
| Device Classification Name: | Keratome (Blade Only) |
| Classification Regulation No.: | CLASS 1, Reserved |
| Classification Panel: | OPHTHALMIC |
| Product Code: | 86 HNO |
Legally marketed device to which we are claiming equivalence:
| Predicate Device Name: | CARRIAZO BARRAQUER II MICROKERATOME (Blade only) |
|------------------------|--------------------------------------------------|
| Manufacturer: | MORIA, Inc. |
| 510(k) Number: | K002191 |
### Description of the Device:
The Surgistar 2420-M2 is a replacement microkeratome blade for the Moria Carriazo Barraquer II Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2420-M2 blades are single-use, disposable blades.
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Page 2 of 2 Summary
### Intended use of the device:
The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
### Summary of Technological characteristics of device compared to predicate device.
| CHARACTERISTICS | MORIA CARRIAZO
BARRAQUER II
MICROKERATOME BLADE
(PREDICATE) | SURGISTAR M2-2420
BLADE |
|----------------------|------------------------------------------------------------------------|----------------------------|
| Intended Use | As Indicated | Same |
| Target population | As Indicated | Same |
| Performance | Indication for use with the
Carriazo Barraquer II
Microkeratome. | Same |
| Blade Material | Low Carbon Stainless Steel | Same |
| Biocompatibility | For Stainless Steel Blades | Same |
| Mechanical Safety | Assured | Same |
| Sterilization Method | ETO | Same |
#### Performance tests and conclusions:
- 6. Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar.
- 7. Sharpness Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade.
- 8. Keratome Fit Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable.
- 9. Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade.
- 10. Conclusion The Surgistar 2420-M2 was demonstrated to be substantially equivalent to the predicate Moria M2 Microkeratome blade.
(Premarket Notification [510(k)] Number)
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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The image is in black and white.
A
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2003
Surgistar, Inc. c/o Jonathan Woodward President 6068 Corte Del Cedro Carlsbad, CA 92009
Re: K030891
Trade/Device Name: Surgistar Microkeratome Blade Models No. 2400-LSK, 2410-CB, and 2420 M2 Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 19, 2003 Received: March 21, 2003
Dear Mr. Jonathan Woodward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
## Page 2 - Mr. Jonathan Woodward
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Paulyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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d.
510(k) Number (if known): 503089|
Device Name: Surgistar 2420-M2 Microkeratome Blade
# Indications for Use
The Surgistar 2420-M2 Microkeratome is indicated for use as a replacement blade in the Moria M2 Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
lit. Köblichers
I hroat I
i Number K030891
(Optional Format 3-10-98)
{9}------------------------------------------------
# March 19, 2003 Premarket Notification
d.
510(k) Number (if known): K030891
Device Name: Surgistar 2400-LSK Microkeratome Blade
# Indications for Use
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
### Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
lukas hicholav
Ophthalmic Ear. Throat Devises
510(k) Number K030891
(Optional Format 3-10-98)
{10}------------------------------------------------
# March 19, 2003 Premarket Notification
ﮯ
510(k) Number (if known): K030891
Device Name: Surgistar 2410-CB Microkeratome Blade
# Indications for Use
The Surgistar 2410-CB Microkeratome is indicated for use as a replacement blade in the Moria Carriazo Barraquer Microkeratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use . (Per 21 CFR 801.109)
Mi R.B. Nicholas
vision of Ophthalmic Ear. Nose and Throat Devises
KO 30891 510(k) Number
(Optional Format 3-10-98)
---
**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K030891](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K030891)
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