Peregrine Surgical, LLC.

FDA Device Registration & Listing · New Britain, PA, US · Registration 2529392

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2529392
FEI Number
1000121498
Entity Name
Peregrine Surgical, LLC.
City/State/Country
New Britain, PA, US
Establishment Address
51 Britain Drive, New Britain, PA 18901, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PEREGRINE SURGICAL LLC (Owner Number: 9002261)
Owner / Operator Contact Address
51 BRITAIN DR., --, New Britain, PA 18901, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Midfield Endoillumination Probe 3269.M04-00,3269.M05-00,3269.M06-00 Peregrine 23ga and 25ga Adjustable Chandelier Illuminator BL5234,BL5235 BL5234,BL5235 Chandeliers G-Probe Exempt PD720.10,PD720.11,PD720.12,PD720.13,PD723.10,PD723.11,PD723.12,PD723.13,PD725.10,PD725.11,PD725.12,PD725.13,BL5290,BL5293,BL5295 Standard (Non-Illuminating) Laser Probes GA-0040025,GA-0040051,GA-0040022,GA-0040046,GA-0040021,GA-0040047,GA-0040012,GA-0040038,GA-0040009,GA-0040035,GA-0040008,GA-0040034 OtoProbe Infusion Sleeve DMEK/DSAEK Infusion Sleeve EndoProbe G-Probe Illuminate Illuminated Laser Probes BL5295L,BL5295LC,GA-0040003,GA-0040004,GA-0040005,GA-0040006,GA-0040010,GA-0040011,GA-0040087,GA-0040089,GA-0040073 PD723.37,PD723.38,PD725.30,PD725.31,PD725.32,PD725.33,PD725.35,PD725.36,PD725.37,PD725.38,BL5290L,BL5290LC,BL5293L,BL5293LC GA-0040075,GA-0040079,GA-0040016,GA-0040017,GA-0040018,GA-0040019,GA-0040023,GA-0040024,GA-0040099,GA-0040101 GA-0040103,GA-0040105,GA-0040113,GA-0040115 PD720.30,PD720.31,PD720.32,PD720.33,PD720.35,PD720.36,PD720.37,PD720.38,PD723.30,PD723.31,PD723.32,PD723.33,PD723.35,PD723.36 DMEK Forceps DMEK/DSAEK Forceps MicroPulse P3 Device GA-0040023,GA-0040024,GA-0040099,GA-0040101,GA-0040103,GA-0040105,GA-0040113,GA-0040115 GA-0040005,GA-0040006,GA-0040010,GA-0040011,GA-0040087,GA-0040089,GA-0040073,GA-0040075,GA-0040079,GA-0040016,GA-0040017,GA-0040018,GA-0040019 PD725.30,PD725.31,PD725.32,PD725.33,PD725.35,PD725.36,PD725.37,PD725.38,BL5290L,BL5290LC,BL5293L,BL5293LC,BL5295L,BL5295LC,GA-0040003,GA-0040004 Illuminated Laser Probes PD720.30,PD720.31,PD720.32,PD720.33,PD720.35,PD720.36,PD720.37,PD720.38,PD723.30,PD723.31,PD723.32,PD723.33,PD723.35,PD723.36,PD723.37,PD723.38 PD100.13, PD123.13 Light Pipes - Peregrine PD720.60/PD720.60HT*,PD720.62/PD720.62HT*,PD723.60/PD723.60HT*,PD723.62/PD723.62HT*,BL5290ASP,BL5290ASPH BL5293ASP,BLS5293ASPH,GA-0040013,GA-0040039,GA-0040000,GA-0040026 Aspirating Laser Probes PD1030,PD103.12,PD103.23,PD1040,PD104.23,PD1233A,PD125.25,PD126.25,PD127.25,PD128.25 PD1000,PD1001,PD1002,PD1003,PD1004,PD1006,PD1007,PD100.12,PD100.23,PD1010,PD1011,PD1012,PD1013,PD1014 PD1016,PD101.11,PD101.23,PD1020,PD1021,PD1022,PD1023,PD1024,PD1026,PD1027,PD102.11,PD102.12,PD102.23 Light Pipes - Peregrine Exempt Acculite Endo Probe - EndoOcular Illuminating Probe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2024-09-04
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2015-09-14
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2013-11-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-10-28
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-11-18
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2007-11-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2007-11-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-10-28
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2018-02-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-10-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-05-01
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2013-11-20
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2013-11-20
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2013-11-20
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2010-08-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-05-01
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2007-11-18
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2008-11-12
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2008-11-12
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2008-11-12
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2008-11-12
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2004-06-21
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2016-06-27

Official Correspondent

Ryan O'Leary

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PEREGRINE SURGICAL LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0307-2026 Alcon Research LLC 2
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0581-2026 Alcon Research LLC 2
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number Establishment Name Location
2246552 Isomedix Operations Inc. S Plainfield, NJ, US
1932402 SYNERGETICS, INC. O Fallon, MO, US
3005941719 Sterigenics Belgium Petit Rechain S.A. Verviers Liege, BE
3019810045 Oculight Co.,Ltd. Seongnam, KR
1928237 MIDWEST STERILIZATION CORP. JACKSON, MO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2529392. Last updated year: 2026. Please use registration number 2529392 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.